#!/usr/bin/env node
import { Server } from '@modelcontextprotocol/sdk/server/index.js';
import { StdioServerTransport } from '@modelcontextprotocol/sdk/server/stdio.js';
import {
CallToolRequestSchema,
ListToolsRequestSchema,
ListPromptsRequestSchema,
GetPromptRequestSchema,
} from '@modelcontextprotocol/sdk/types.js';
import { lookupDrug, lookupDevice } from './fda-search.js';
const server = new Server(
{
name: 'fda-mcp-server',
version: '0.3.3',
},
{
capabilities: {
tools: {},
prompts: {},
},
}
);
// List available tools
server.setRequestHandler(ListToolsRequestSchema, async () => {
return {
tools: [
{
name: 'fda_info',
description: 'Unified tool for FDA drug and medical device information lookup. Access drug labels, adverse events, regulatory information, recalls, shortages, and device registration data from the openFDA database.',
inputSchema: {
type: 'object',
properties: {
method: {
type: 'string',
enum: ['lookup_drug', 'lookup_device'],
description: 'The operation to perform: lookup_drug (search across multiple relevant fields, or search a specific field if field parameter is provided), lookup_device (search device registration and listing data)'
},
search_term: {
type: 'string',
description: 'Search term to look for in the FDA database. Can be a drug name (generic or brand), manufacturer name, dosage form, marketing status, or any other searchable value. Supports wildcards (*), phrase matches ("term"), boolean operators (AND, OR), field combinations, date ranges, and special modifiers (_missing_, _exists_). Examples: Simple: "aspirin", "PFIZER"; Field searches: "sponsor_name:PFIZER", "products.brand_name:VISTARIL"; Complex: "sponsor_name:\\"PFIZER\\"+AND+products.dosage_form:\\"CAPSULE\\"", "(products.dosage_form:\\"TABLET\\"+OR+products.dosage_form:\\"CAPSULE\\")+AND+sponsor_name:\\"PFIZER\\"; Date ranges: "receivedate:[20240101+TO+20241231]", "receivedate:[20240815+TO+20240915]+AND+patient.drug.medicinalproduct:semaglutide"'
},
search_type: {
type: 'string',
enum: ['general', 'label', 'adverse_events', 'recalls', 'shortages', 'device_registration', 'device_pma', 'device_510k', 'device_udi', 'device_recalls', 'device_adverse_events', 'device_classification'],
default: 'general',
description: 'Type of information to retrieve. For drugs: "general" for comprehensive search, "label" for prescribing information, "adverse_events" for safety data, "recalls" for drug recalls, "shortages" for supply shortages. For devices: "device_registration" for medical device registration and listing data, "device_pma" for Pre-Market Approval (PMA) decisions and submissions, "device_510k" for 510(k) premarket notification clearances, "device_udi" for Unique Device Identifier (UDI) database information, "device_recalls" for device recalls and enforcement reports, "device_adverse_events" for medical device adverse event reports, "device_classification" for device classification and regulatory information'
},
fields_for_general: {
type: 'string',
description: `Optional field to search within general drug data. Common categories:
• Top-level: application_number, sponsor_name
• OpenFDA: openfda.brand_name, openfda.generic_name, openfda.manufacturer_name, openfda.route, openfda.product_type
• Products: products.active_ingredients.name, products.dosage_form, products.marketing_status, products.brand_name
• Submissions: submissions.submission_status, submissions.review_priority, submissions.application_docs.date, submissions.application_docs.type
See examples for usage patterns.`,
enum: [
'application_number',
'sponsor_name',
'openfda.application_number',
'openfda.brand_name',
'openfda.generic_name',
'openfda.manufacturer_name',
'openfda.nui',
'openfda.package_ndc',
'openfda.pharm_class_cs',
'openfda.pharm_class_epc',
'openfda.pharm_class_pe',
'openfda.pharm_class_moa',
'openfda.product_ndc',
'openfda.product_type',
'openfda.route',
'openfda.rxcui',
'openfda.spl_id',
'openfda.spl_set_id',
'openfda.substance_name',
'openfda.unii',
'openfda.upc',
'openfda.dosage_form',
'openfda.is_original_packager',
'openfda.original_packager_product_ndc',
'products.active_ingredients.name',
'products.active_ingredients.strength',
'products.brand_name',
'products.dosage_form',
'products.marketing_status',
'products.product_number',
'products.reference_drug',
'products.reference_standard',
'products.route',
'products.te_code',
'submissions.application_docs.date',
'submissions.application_docs.type',
'submissions.application_docs.url',
'submissions.review_priority',
'submissions.submission_class_code',
'submissions.submission_class_code_description',
'submissions.submission_number',
'submissions.submission_property_type.code',
'submissions.submission_public_notes',
'submissions.submission_status',
'submissions.submission_status_date',
'submissions.submission_type'
]
},
fields_for_adverse_events: {
type: 'string',
description: `Optional field to search within adverse events data. Common categories:
• Report Info: serious, occurcountry, receiptdate, safetyreportid
• Patient: patient.patientsex, patient.patientonsetage, patient.patientweight
• Drug: patient.drug.medicinalproduct, patient.drug.drugindication, patient.drug.drugcharacterization
• Reactions: patient.reaction.reactionmeddrapt, patient.reaction.reactionoutcome
See examples for usage patterns.`,
enum: [
'authoritynumb',
'companynumb',
'duplicate',
'fulfillexpeditecriteria',
'occurcountry',
'receiptdate',
'receiptdateformat',
'receivedate',
'receivedateformat',
'reporttype',
'safetyreportid',
'safetyreportversion',
'serious',
'transmissiondate',
'transmissiondateformat',
'patient.drug.actiondrug',
'patient.drug.activesubstance.activesubstancename',
'patient.drug.drugadditional',
'patient.drug.drugauthorizationnumb',
'patient.drug.drugbatchnumb',
'patient.drug.drugcharacterization',
'patient.drug.drugcumulativedosagenumb',
'patient.drug.drugcumulativedosageunit',
'patient.drug.drugdosagetext',
'patient.drug.drugenddate',
'patient.drug.drugenddateformat',
'patient.drug.drugindication',
'patient.drug.drugintervaldosagedefinition',
'patient.drug.drugintervaldosageunitnumb',
'patient.drug.medicinalproduct',
'patient.drug.drugrecurreadministration',
'patient.drug.drugrecurrence',
'patient.drug.drugseparatedosagenumb',
'patient.drug.drugstartdate',
'patient.drug.drugstartdateformat',
'patient.drug.drugstructuredosagenumb',
'patient.drug.drugstructuredosageunit',
'patient.drug.drugtreatmentduration',
'patient.drug.drugtreatmentdurationunit',
'patient.patientagegroup',
'patient.patientdeath.patientdeathdate',
'patient.patientdeath.patientdeathdateformat',
'patient.patientonsetage',
'patient.patientonsetageunit',
'patient.patientsex',
'patient.patientweight',
'patient.reaction.reactionmeddrapt',
'patient.reaction.reactionmeddraversionpt',
'patient.reaction.reactionoutcome',
'patient.summary.narrativeincludeclinical',
'primarysource.literaturereference',
'primarysource.qualification',
'primarysource.reportercountry',
'primarysource.primarysourcecountry',
'receiver.receiverorganization',
'receiver.receivertype',
'reportduplicate.duplicatenumb',
'reportduplicate.duplicatesource',
'sender.senderorganization',
'sender.sendertype',
'seriousnesscongenitalanomali',
'seriousnessdeath',
'seriousnessdisabling',
'seriousnesshospitalization',
'seriousnesslifethreatening',
'seriousnessother'
]
},
fields_for_label: {
type: 'string',
description: `Optional field to search within drug labels. Common categories:
• Clinical: warnings, indications_and_usage, dosage_and_administration, contraindications, drug_interactions
• Populations: pediatric_use, geriatric_use, pregnancy, hepatic_impairment, renal_impairment
• Product Info: openfda.brand_name, openfda.generic_name, boxed_warning, how_supplied
• Safety: adverse_reactions, overdosage, controlled_substance, abuse
See examples for usage patterns.`,
enum: [
'effective_time',
'inactive_ingredient',
'spl_product_data_elements',
'purpose',
'version',
'ask_doctor',
'ask_doctor_or_pharmacist',
'do_not_use',
'openfda.application_number',
'openfda.brand_name',
'openfda.generic_name',
'openfda.manufacturer_name',
'openfda.product_ndc',
'openfda.product_type',
'openfda.route',
'openfda.substance_name',
'openfda.rxcui',
'openfda.spl_id',
'openfda.spl_set_id',
'openfda.package_ndc',
'openfda.nui',
'openfda.pharm_class_epc',
'openfda.pharm_class_pe',
'openfda.pharm_class_moa',
'openfda.pharm_class_cs',
'openfda.unii',
'warnings',
'indications_and_usage',
'dosage_and_administration',
'dosage_forms_and_strengths',
'contraindications',
'warnings_and_cautions',
'adverse_reactions',
'drug_interactions',
'use_in_specific_populations',
'drug_abuse_and_dependence',
'overdosage',
'description',
'clinical_pharmacology',
'nonclinical_toxicology',
'clinical_studies',
'references',
'how_supplied',
'storage_and_handling',
'patient_counseling_information',
'boxed_warning',
'recent_major_changes',
'brand_name_base',
'generic_name_base',
'labeler_name',
'product_id',
'product_ndc',
'application_number',
'sponsor_name',
'fullname',
'appl_type',
'appl_no',
'product_no',
'te_code',
'approval_date',
'rld',
'type',
'applicant',
'strength',
'df_route',
'trade_name',
'applicant_full_name',
'dosage_form',
'marketing_status',
'chemical_name',
'active_ingredient',
'drug_name',
'manufacturer_name',
'pharm_class',
'indication_class',
'schedule',
'nda_number',
'application_type',
'submission_type',
'submission_number',
'submission_status',
'submission_status_date',
'marketing_category',
'dosage_form_name',
'route_name',
'marketing_category_name',
'pharm_class_epc',
'pharm_class_pe',
'pharm_class_moa',
'pharm_class_cs',
'dea_schedule',
'listing_expiration_date',
'openfda.is_original_packager',
'openfda.upc',
'set_id',
'id',
'spl_version',
'document_type',
'effective_date',
'version_number',
'pregnancy_or_breast_feeding',
'geriatric_use',
'pediatric_use',
'animal_pharmacology_and_or_toxicology',
'controlled_substance',
'abuse',
'dependence',
'carcinogenesis_and_mutagenesis_and_impairment_of_fertility',
'pregnancy',
'labor_and_delivery',
'nursing_mothers',
'information_for_patients',
'laboratory_tests',
'carcinogenesis_mutagenesis_impairment_of_fertility',
'teratogenic_effects',
'nonteratogenic_effects',
'labor_delivery',
'nursing_mothers_subsection',
'pediatric_use_subsection',
'geriatric_use_subsection',
'hepatic_impairment',
'renal_impairment',
'female_and_male_of_reproductive_potential',
'lactation',
'females_and_males_of_reproductive_potential',
'pediatric_patients',
'geriatric_patients',
'hepatic_impairment_subsection',
'renal_impairment_subsection',
'immunocompromised_patients',
'race_ethnicity',
'keep_out_of_reach_of_children',
'questions',
'package_label_principal_display_panel',
'spl_medguide',
'spl_patient_package_insert',
'information_for_the_patient',
'instructions_for_use',
'medication_guide',
'user_safety_warnings',
'precautions',
'when_using',
'stop_use',
'pregnancy_breast_feeding',
'keep_out_of_reach',
'directions',
'other_information',
'principal_display_panel',
'active_ingredient_section',
'inactive_ingredient_section',
'warnings_section',
'when_using_section',
'stop_use_section',
'directions_section',
'other_information_section',
'questions_section',
'package_label_section',
'carton_labeling',
'container_labeling',
'blister_pack_labeling',
'bottle_labeling',
'tube_labeling',
'pouch_labeling',
'syringe_labeling',
'vial_labeling',
'ampule_labeling',
'prefilled_syringe_labeling'
]
},
fields_for_recalls: {
type: 'string',
description: `Optional field to search within drug recalls and enforcement reports. Common categories:
• Recall Info: recalling_firm, classification, status, reason_for_recall, product_type, voluntary_mandated
• Product Details: product_description, code_info, more_code_info, product_quantity, distribution_pattern
• Timeline: report_date, recall_initiation_date, center_classification_date, termination_date, initial_firm_notification
• Tracking: recall_number, event_id
• Geographic: address_1, address_2, city, state, country, postal_code
• OpenFDA: openfda.brand_name, openfda.generic_name, openfda.manufacturer_name, openfda.product_ndc
See examples for usage patterns.`,
enum: [
'recalling_firm',
'classification',
'status',
'distribution_pattern',
'product_description',
'code_info',
'more_code_info',
'reason_for_recall',
'product_quantity',
'voluntary_mandated',
'report_date',
'recall_initiation_date',
'center_classification_date',
'termination_date',
'initial_firm_notification',
'recall_number',
'event_id',
'product_type',
'address_1',
'address_2',
'city',
'state',
'country',
'postal_code',
'openfda.application_number',
'openfda.brand_name',
'openfda.generic_name',
'openfda.manufacturer_name',
'openfda.nui',
'openfda.package_ndc',
'openfda.pharm_class_cs',
'openfda.pharm_class_epc',
'openfda.pharm_class_pe',
'openfda.pharm_class_moa',
'openfda.product_ndc',
'openfda.route',
'openfda.rxcui',
'openfda.spl_id',
'openfda.spl_set_id',
'openfda.substance_name',
'openfda.unii',
'openfda.upc'
]
},
fields_for_shortages: {
type: 'string',
description: `Optional field to search within drug shortages data. Common categories:
• Product Info: generic_name, proprietary_name, brand_name, company_name, product_id, presentation
• Shortage Details: status, availability, shortage_reason, therapeutic_category, resolved_note
• Timeline: update_date, change_date, discontinued_date, initial_posting_date, update_type
• Contact & Links: contact_info, related_info, related_info_link
• Technical: package_ndc, dosage_form, strength
• OpenFDA: openfda.application_number, openfda.brand_name, openfda.generic_name, openfda.manufacturer_name, openfda.product_ndc, openfda.route, openfda.substance_name
See examples for usage patterns.`,
enum: [
'package_ndc',
'generic_name',
'proprietary_name',
'company_name',
'contact_info',
'presentation',
'product_id',
'update_type',
'availability',
'related_info',
'related_info_link',
'resolved_note',
'shortage_reason',
'therapeutic_category',
'dosage_form',
'strength',
'status',
'update_date',
'change_date',
'discontinued_date',
'initial_posting_date',
'openfda.application_number',
'openfda.brand_name',
'openfda.dosage_form',
'openfda.generic_name',
'openfda.is_original_packager',
'openfda.manufacturer_name',
'openfda.nui',
'openfda.original_packager_product_ndc',
'openfda.package_ndc',
'openfda.pharm_class_cs',
'openfda.pharm_class_epc',
'openfda.pharm_class_moa',
'openfda.pharm_class_pe',
'openfda.product_ndc',
'openfda.product_type',
'openfda.route',
'openfda.rxcui',
'openfda.spl_id',
'openfda.spl_set_id',
'openfda.substance_name',
'openfda.unii',
'openfda.upc'
]
},
fields_for_device_registration: {
type: 'string',
description: `Optional field to search within device registration and listing data. Common categories:
• Device Info: proprietary_name, establishment_type, pma_number, k_number
• Registration: registration.registration_number, registration.fei_number, registration.name, registration.status_code
• Location: registration.city, registration.state_code, registration.iso_country_code, registration.zip_code
• Products: products.product_code, products.created_date, products.exempt
• OpenFDA: products.openfda.device_name, products.openfda.device_class, products.openfda.regulation_number, products.openfda.medical_specialty_description
• Contact: registration.us_agent.name, registration.us_agent.business_name, registration.owner_operator.firm_name
See examples for usage patterns.`,
enum: [
'proprietary_name',
'establishment_type',
'pma_number',
'k_number',
'registration.registration_number',
'registration.fei_number',
'registration.status_code',
'registration.initial_importer_flag',
'registration.reg_expiry_date_year',
'registration.name',
'registration.address_line_1',
'registration.address_line_2',
'registration.city',
'registration.state_code',
'registration.iso_country_code',
'registration.zip_code',
'registration.postal_code',
'registration.us_agent.name',
'registration.us_agent.business_name',
'registration.us_agent.bus_phone_area_code',
'registration.us_agent.bus_phone_num',
'registration.us_agent.bus_phone_extn',
'registration.us_agent.fax_area_code',
'registration.us_agent.fax_num',
'registration.us_agent.email_address',
'registration.us_agent.address_line_1',
'registration.us_agent.address_line_2',
'registration.us_agent.city',
'registration.us_agent.state_code',
'registration.us_agent.iso_country_code',
'registration.us_agent.zip_code',
'registration.us_agent.postal_code',
'registration.owner_operator.firm_name',
'registration.owner_operator.owner_operator_number',
'registration.owner_operator.contact_address.address_1',
'registration.owner_operator.contact_address.address_2',
'registration.owner_operator.contact_address.city',
'registration.owner_operator.contact_address.state_code',
'registration.owner_operator.contact_address.state_province',
'registration.owner_operator.contact_address.iso_country_code',
'registration.owner_operator.contact_address.postal_code',
'products.product_code',
'products.created_date',
'products.owner_operator_number',
'products.exempt',
'products.openfda.k_number',
'products.openfda.device_name',
'products.openfda.medical_specialty_description',
'products.openfda.regulation_number',
'products.openfda.device_class'
]
},
fields_for_device_pma: {
type: 'string',
description: `Optional field to search within device PMA (Pre-Market Approval) data. Common categories:
• Application Info: pma_number, supplement_number, supplement_type, supplement_reason, expedited_review_flag
• Company: applicant, street_1, street_2, city, state, zip, zip_ext
• Device Info: generic_name, trade_name, product_code, advisory_committee, advisory_committee_description
• Timeline: date_received, decision_date, docket_number
• Decision: decision_code, ao_statement
• OpenFDA: openfda.device_name, openfda.device_class, openfda.medical_specialty_description, openfda.regulation_number
See examples for usage patterns.`,
enum: [
'pma_number',
'supplement_number',
'applicant',
'street_1',
'street_2',
'city',
'state',
'zip',
'zip_ext',
'generic_name',
'trade_name',
'product_code',
'advisory_committee',
'advisory_committee_description',
'supplement_type',
'supplement_reason',
'expedited_review_flag',
'date_received',
'decision_date',
'docket_number',
'decision_code',
'ao_statement',
'openfda.registration_number',
'openfda.fei_number',
'openfda.device_name',
'openfda.medical_specialty_description',
'openfda.regulation_number',
'openfda.device_class'
]
},
fields_for_device_510k: {
type: 'string',
description: `Optional field to search within device 510(k) clearance data. Common categories:
• Application Info: k_number, third_party_flag, statement_or_summary, clearance_type, expedited_review_flag
• Company: applicant, address_1, address_2, city, state, zip_code, postal_code, country_code, contact
• Device Info: device_name, product_code, advisory_committee, advisory_committee_description, review_advisory_committee
• Timeline: date_received, decision_date, decision_code, decision_description
• OpenFDA: openfda.device_name, openfda.device_class, openfda.regulation_number, openfda.medical_specialty_description
See examples for usage patterns.`,
enum: [
'k_number',
'third_party_flag',
'statement_or_summary',
'clearance_type',
'expedited_review_flag',
'applicant',
'address_1',
'address_2',
'city',
'state',
'zip_code',
'postal_code',
'country_code',
'contact',
'device_name',
'product_code',
'advisory_committee',
'advisory_committee_description',
'review_advisory_committee',
'date_received',
'decision_date',
'decision_code',
'decision_description',
'openfda.registration_number',
'openfda.fei_number',
'openfda.device_name',
'openfda.medical_specialty_description',
'openfda.regulation_number',
'openfda.device_class'
]
},
fields_for_device_udi: {
type: 'string',
description: `Optional field to search within device UDI (Unique Device Identifier) data. Common categories:
• Device Info: device_description, brand_name, company_name, version_or_model_number, catalog_number
• Status & Record: public_device_record_key, public_version_status, record_status, commercial_distribution_status, public_version_date
• Device Properties: is_rx, is_otc, is_single_use, is_combination_product, is_kit, has_serial_number, has_manufacturing_date
• Safety: mri_safety, sterilization.is_sterile, sterilization.sterilization_methods
• Classification: product_codes.code, product_codes.name, product_codes.openfda.device_name, product_codes.openfda.device_class
• GMDN: gmdn_terms.code, gmdn_terms.name, gmdn_terms.definition
• Identifiers: identifiers.id, identifiers.type, identifiers.issuing_agency, labeler_duns_number
See examples for usage patterns.`,
enum: [
'device_description',
'brand_name',
'company_name',
'version_or_model_number',
'catalog_number',
'public_device_record_key',
'public_version_status',
'record_status',
'commercial_distribution_status',
'public_version_date',
'public_version_number',
'publish_date',
'is_rx',
'is_otc',
'is_single_use',
'is_combination_product',
'is_kit',
'has_serial_number',
'has_manufacturing_date',
'has_lot_or_batch_number',
'has_expiration_date',
'has_donation_id_number',
'is_labeled_as_nrl',
'is_labeled_as_no_nrl',
'is_direct_marking_exempt',
'is_pm_exempt',
'is_hct_p',
'device_count_in_base_package',
'mri_safety',
'sterilization.is_sterile',
'sterilization.is_sterilization_prior_use',
'sterilization.sterilization_methods',
'product_codes.code',
'product_codes.name',
'product_codes.openfda.device_name',
'product_codes.openfda.medical_specialty_description',
'product_codes.openfda.regulation_number',
'product_codes.openfda.device_class',
'gmdn_terms.code',
'gmdn_terms.name',
'gmdn_terms.definition',
'gmdn_terms.implantable',
'gmdn_terms.code_status',
'identifiers.id',
'identifiers.type',
'identifiers.issuing_agency',
'labeler_duns_number',
'customer_contacts.phone',
'customer_contacts.email'
]
},
fields_for_device_recalls: {
type: 'string',
description: `Optional field to search within device enforcement (recall) data. Common categories:
• Recall Info: classification, status, voluntary_mandated, reason_for_recall, product_type
• Company & Location: recalling_firm, city, state, country, address_1, address_2, postal_code
• Product Details: product_description, product_quantity, code_info, more_code_info
• Timeline: report_date, recall_initiation_date, center_classification_date
• Distribution: distribution_pattern, initial_firm_notification
• Tracking: recall_number, event_id
• OpenFDA: openfda fields for additional device information
See examples for usage patterns.`,
enum: [
'classification',
'status',
'city',
'state',
'country',
'product_type',
'event_id',
'recalling_firm',
'address_1',
'address_2',
'postal_code',
'voluntary_mandated',
'initial_firm_notification',
'distribution_pattern',
'recall_number',
'product_description',
'product_quantity',
'reason_for_recall',
'recall_initiation_date',
'center_classification_date',
'report_date',
'code_info',
'more_code_info',
'openfda.device_name',
'openfda.device_class',
'openfda.regulation_number',
'openfda.medical_specialty_description',
'openfda.product_code',
'openfda.registration_number',
'openfda.fei_number'
]
},
fields_for_device_adverse_events: {
type: 'string',
description: `Optional field to search within device adverse event data. Common categories:
• Report Info: date_received, report_date, event_type, report_number, type_of_report, report_source_code, adverse_event_flag
• Device Info: device.brand_name, device.generic_name, device.model_number, device.manufacturer_d_name, device.device_report_product_code
• Patient Info: patient.patient_age, patient.patient_sex, patient.sequence_number_outcome, patient.patient_weight, patient.patient_race
• Event Details: event_location, mdr_text.text_type_code, mdr_text.text, remedial_action, date_of_event
• Manufacturer: manufacturer_name, manufacturer_city, manufacturer_state, manufacturer_country
• OpenFDA: device.openfda.device_name, device.openfda.device_class, device.openfda.regulation_number, device.openfda.medical_specialty_description
See examples for usage patterns.`,
enum: [
'date_received',
'date_report',
'date_of_event',
'date_facility_aware',
'date_report_to_fda',
'event_type',
'report_number',
'type_of_report',
'report_source_code',
'adverse_event_flag',
'product_problem_flag',
'event_location',
'health_professional',
'initial_report_to_fda',
'report_to_fda',
'report_to_manufacturer',
'mdr_report_key',
'single_use_flag',
'previous_use_code',
'remedial_action',
'removal_correction_number',
'manufacturer_name',
'manufacturer_address_1',
'manufacturer_address_2',
'manufacturer_city',
'manufacturer_state',
'manufacturer_zip_code',
'manufacturer_country',
'manufacturer_postal_code',
'manufacturer_contact_f_name',
'manufacturer_contact_l_name',
'manufacturer_contact_t_name',
'manufacturer_contact_phone_number',
'manufacturer_contact_extension',
'manufacturer_contact_city',
'manufacturer_contact_state',
'manufacturer_contact_zip_code',
'manufacturer_contact_country',
'device.brand_name',
'device.generic_name',
'device.manufacturer_d_name',
'device.manufacturer_d_city',
'device.manufacturer_d_state',
'device.manufacturer_d_country',
'device.model_number',
'device.catalog_number',
'device.lot_number',
'device.device_report_product_code',
'device.device_operator',
'device.device_availability',
'device.implant_flag',
'device.device_age_text',
'device.device_evaluated_by_manufacturer',
'device.openfda.device_name',
'device.openfda.medical_specialty_description',
'device.openfda.regulation_number',
'device.openfda.device_class',
'patient.patient_age',
'patient.patient_sex',
'patient.patient_weight',
'patient.patient_ethnicity',
'patient.patient_race',
'patient.sequence_number_treatment',
'patient.sequence_number_outcome',
'mdr_text.text_type_code',
'mdr_text.text',
'distributor_name',
'distributor_address_1',
'distributor_city',
'distributor_state',
'distributor_zip_code'
]
},
fields_for_device_classification: {
type: 'string',
description: `Optional field to search within device classification data. Common categories:
• Basic Info: product_code, device_name, device_class, regulation_number
• Medical Specialty: medical_specialty, medical_specialty_description, review_panel
• Classification Details: definition, unclassified_reason, review_code, submission_type_id
• Flags: implant_flag, life_sustain_support_flag, gmp_exempt_flag, third_party_flag
• Reporting: summary_malfunction_reporting
• OpenFDA: openfda.k_number, openfda.registration_number, openfda.fei_number
See examples for usage patterns.`,
enum: [
'product_code',
'device_name',
'device_class',
'regulation_number',
'medical_specialty',
'medical_specialty_description',
'review_panel',
'definition',
'unclassified_reason',
'review_code',
'submission_type_id',
'implant_flag',
'life_sustain_support_flag',
'gmp_exempt_flag',
'third_party_flag',
'summary_malfunction_reporting',
'openfda.k_number',
'openfda.registration_number',
'openfda.fei_number'
]
},
count: {
type: 'string',
description: 'Field to count/aggregate results by. Usage of .exact suffix depends on search_type:',
examples: [
// General searches - no .exact
'sponsor_name',
'application_number',
'openfda.product_type',
// Adverse events - .exact for text fields, not for simple fields
'patient.reaction.reactionmeddrapt.exact',
'patient.patientsex',
'receivedate',
// Labels - .exact for aggregation fields
'openfda.product_type.exact',
'openfda.manufacturer_name.exact'
],
additionalProperties: {
'search_type guidance': {
'general': 'Use field names as-is (no .exact suffix)',
'adverse_events': 'Add .exact for text/categorical fields, omit for numeric/date fields',
'label': 'Add .exact for text aggregation fields'
}
}
},
pharm_class: {
type: 'string',
description: 'Search by pharmacological class (drug class). This parameter automatically constructs the proper search for patient.drug.openfda.pharm_class_epc field. Useful for finding adverse events associated with specific drug classes like NSAIDs, antibiotics, antidepressants, etc. Can be combined with other search terms.',
examples: [
'nonsteroidal anti-inflammatory drug',
'selective serotonin reuptake inhibitor',
'angiotensin converting enzyme inhibitor',
'beta blocker',
'proton pump inhibitor',
'antihistamine',
'anticoagulant',
'diuretic',
'antidepressant',
'antibiotic',
'corticosteroid',
'benzodiazepine',
'opioid',
'statin',
'calcium channel blocker'
]
},
field_exists: {
type: 'string',
description: 'Filter records to only those that contain a specific field, regardless of field contents. Uses FDA\'s "_exists_" search modifier. Works with both drug labels and adverse events data. For labels: find drugs with specific information like boxed warnings, contraindications, etc. For adverse events: find reports with specific data like patient demographics, drug information, reactions, etc.',
examples: [
'boxed_warning',
'contraindications',
'drug_interactions',
'warnings_and_cautions',
'adverse_reactions',
'indications_and_usage',
'dosage_and_administration',
'clinical_pharmacology',
'pregnancy',
'nursing_mothers',
'pediatric_use',
'geriatric_use',
'patient.reaction.reactionmeddrapt',
'patient.patientsex',
'patient.patientonsetage',
'patient.drug.medicinalproduct',
'patient.drug.drugindication',
'serious',
'occurcountry'
]
},
limit: {
type: 'integer',
default: 10,
minimum: 1,
maximum: 100,
description: 'Maximum number of records to return (default: 10, max: 100). Note: openFDA supports paging through up to 26,000 total hits using skip/limit parameters.',
examples: [1, 5, 10, 25, 50, 100]
}
},
required: ['method', 'search_term'],
additionalProperties: false,
examples: [
{
description: "Basic search for aspirin across all general FDA database fields",
usage: {
"method": "lookup_drug",
"search_term": "aspirin",
"search_type": "general",
"limit": 10
}
},
{
description: "Find Tylenol products by searching specifically in brand name field",
usage: {
"method": "lookup_drug",
"search_term": "Tylenol",
"search_type": "general",
"fields_for_general": "openfda.brand_name",
"limit": 5
}
},
{
description: "Search drug labels for specific warnings content",
usage: {
"method": "lookup_drug",
"search_term": "pregnancy",
"search_type": "label",
"fields_for_label": "warnings",
"limit": 10
}
},
{
description: "Find drug labels with specific indications and usage information",
usage: {
"method": "lookup_drug",
"search_term": "diabetes",
"search_type": "label",
"fields_for_label": "indications_and_usage"
}
},
{
description: "Search drug labels within a specific date range (Jun 2011 to Dec 2012)",
usage: {
"method": "lookup_drug",
"search_term": "effective_time:[20110601+TO+20121231]",
"search_type": "label",
"limit": 5
}
},
{
description: "Find all drug labels that have boxed warnings",
usage: {
"method": "lookup_drug",
"search_term": "*",
"search_type": "label",
"field_exists": "boxed_warning",
"limit": 10
}
},
{
description: "Search for specific drug interactions in labels",
usage: {
"method": "lookup_drug",
"search_term": "warfarin",
"search_type": "label",
"fields_for_label": "drug_interactions"
}
},
{
description: "Find dosage information for pediatric patients",
usage: {
"method": "lookup_drug",
"search_term": "pediatric",
"search_type": "label",
"fields_for_label": "dosage_and_administration"
}
},
{
description: "Search for contraindications containing specific conditions",
usage: {
"method": "lookup_drug",
"search_term": "kidney",
"search_type": "label",
"fields_for_label": "contraindications"
}
},
{
description: "Find labels with boxed warnings AND pregnancy-related contraindications",
usage: {
"method": "lookup_drug",
"search_term": "_exists_:boxed_warning+AND+contraindications:pregnancy",
"search_type": "label",
"limit": 5
}
},
{
description: "Search labels mentioning pregnancy OR breastfeeding in warnings sections",
usage: {
"method": "lookup_drug",
"search_term": "warnings:pregnancy+OR+warnings:breastfeeding+OR+warnings:\"breast+feeding\"",
"search_type": "label",
"limit": 10
}
},
{
description: "Find labels with warfarin interactions AND tablet dosage forms",
usage: {
"method": "lookup_drug",
"search_term": "drug_interactions:warfarin+AND+openfda.product_type:\"HUMAN+PRESCRIPTION+DRUG\"",
"search_type": "label"
}
},
{
description: "Search recent labels (2020+) with pediatric dosage information",
usage: {
"method": "lookup_drug",
"search_term": "effective_time:[20200101+TO+*]+AND+dosage_and_administration:pediatric",
"search_type": "label",
"limit": 15
}
},
{
description: "Find naproxen labels with boxed warnings using the new parameter",
usage: {
"method": "lookup_drug",
"search_term": "naproxen",
"search_type": "label",
"field_exists": "boxed_warning",
"limit": 5
}
},
{
description: "Count drug labels by product type (OTC vs Prescription)",
usage: {
"method": "lookup_drug",
"search_term": "*",
"search_type": "label",
"count": "openfda.product_type.exact",
"limit": 10
}
},
{
description: "Count boxed warning drugs by manufacturer",
usage: {
"method": "lookup_drug",
"search_term": "*",
"search_type": "label",
"field_exists": "boxed_warning",
"count": "openfda.manufacturer_name.exact",
"limit": 15
}
},
{
description: "Find drugs that have contraindications information",
usage: {
"method": "lookup_drug",
"search_term": "*",
"search_type": "label",
"field_exists": "contraindications",
"limit": 8
}
},
{
description: "Find drugs with drug interaction information",
usage: {
"method": "lookup_drug",
"search_term": "*",
"search_type": "label",
"field_exists": "drug_interactions",
"limit": 10
}
},
{
description: "Count drugs by whether they have pregnancy information",
usage: {
"method": "lookup_drug",
"search_term": "*",
"search_type": "label",
"field_exists": "pregnancy",
"count": "openfda.product_type.exact",
"limit": 5
}
},
{
description: "Find labels with hepatic impairment warnings AND renal contraindications",
usage: {
"method": "lookup_drug",
"search_term": "warnings:\"hepatic+impairment\"+AND+contraindications:renal",
"search_type": "label"
}
},
{
description: "Search for diabetes medications with cardiovascular warnings",
usage: {
"method": "lookup_drug",
"search_term": "indications_and_usage:diabetes+AND+(warnings:cardiovascular+OR+warnings:cardiac+OR+warnings:heart)",
"search_type": "label",
"limit": 20
}
},
{
description: "Find injectable drugs with specific storage requirements",
usage: {
"method": "lookup_drug",
"search_term": "openfda.route:\"INTRAVENOUS\"+AND+storage_and_handling:refrigerat*",
"search_type": "label"
}
},
{
description: "Search labels with geriatric use info AND drug interaction warnings",
usage: {
"method": "lookup_drug",
"search_term": "_exists_:geriatric_use+AND+_exists_:drug_interactions",
"search_type": "label",
"limit": 25
}
},
{
description: "Wildcard search for all brand names starting with 'child'",
usage: {
"method": "lookup_drug",
"search_term": "child*",
"search_type": "general",
"fields_for_general": "openfda.brand_name"
}
},
{
description: "Search adverse events database for acetaminophen-related reports",
usage: {
"method": "lookup_drug",
"search_term": "acetaminophen",
"search_type": "adverse_events",
"limit": 25
}
},
{
description: "Find adverse events where patients experienced headaches",
usage: {
"method": "lookup_drug",
"search_term": "headache",
"search_type": "adverse_events",
"fields_for_adverse_events": "patient.reaction.reactionmeddrapt"
}
},
{
description: "Search for serious adverse events (hospitalization, death, etc.)",
usage: {
"method": "lookup_drug",
"search_term": "serious:1",
"search_type": "adverse_events",
"fields_for_adverse_events": "serious",
"limit": 50
}
},
{
description: "Find drugs indicated for multiple myeloma using exact phrase search",
usage: {
"method": "lookup_drug",
"search_term": "\"multiple+myeloma\"",
"search_type": "adverse_events",
"fields_for_adverse_events": "patient.drug.drugindication"
}
},
{
description: "Search for adverse events involving antihistamines (multiple drug names)",
usage: {
"method": "lookup_drug",
"search_term": "cetirizine+OR+loratadine+OR+diphenhydramine",
"search_type": "adverse_events",
"fields_for_adverse_events": "patient.drug.medicinalproduct"
}
},
{
description: "Find public-submitted adverse event reports (no company number)",
usage: {
"method": "lookup_drug",
"search_term": "_missing_:companynumb",
"search_type": "adverse_events"
}
},
{
description: "Find adverse event reports that have patient reaction data",
usage: {
"method": "lookup_drug",
"search_term": "*",
"search_type": "adverse_events",
"field_exists": "patient.reaction.reactionmeddrapt",
"limit": 10
}
},
{
description: "Find adverse events that have patient sex information",
usage: {
"method": "lookup_drug",
"search_term": "*",
"search_type": "adverse_events",
"field_exists": "patient.patientsex",
"limit": 20
}
},
{
description: "Find adverse events for aspirin that have patient age data",
usage: {
"method": "lookup_drug",
"search_term": "aspirin",
"search_type": "adverse_events",
"field_exists": "patient.patientonsetage",
"limit": 15
}
},
{
description: "Find adverse events that have drug indication information",
usage: {
"method": "lookup_drug",
"search_term": "*",
"search_type": "adverse_events",
"field_exists": "patient.drug.drugindication",
"limit": 25
}
},
{
description: "Search for tablet dosage form products only",
usage: {
"method": "lookup_drug",
"search_term": "TABLET",
"search_type": "general",
"fields_for_general": "products.dosage_form"
}
},
{
description: "Find aspirin products that are tablets (basic AND query)",
usage: {
"method": "lookup_drug",
"search_term": "openfda.generic_name:aspirin+AND+products.dosage_form:TABLET",
"search_type": "general",
"limit": 5
}
},
{
description: "Find Tylenol products that are specifically tablets (multi-field search)",
usage: {
"method": "lookup_drug",
"search_term": "openfda.brand_name:tylenol+AND+products.dosage_form:tablet",
"search_type": "general",
"limit": 20
}
},
{
description: "Search for oral medications made by Pfizer",
usage: {
"method": "lookup_drug",
"search_term": "openfda.manufacturer_name:pfizer+AND+openfda.route:oral",
"search_type": "general"
}
},
{
description: "Find products with ibuprofen generic name OR Advil brand name",
usage: {
"method": "lookup_drug",
"search_term": "openfda.generic_name:ibuprofen+OR+openfda.brand_name:advil",
"search_type": "general",
"limit": 15
}
},
{
description: "Find aspirin adverse events in male patients only",
usage: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:aspirin+AND+patient.patientsex:1",
"search_type": "adverse_events",
"limit": 30
}
},
{
description: "Search serious acetaminophen adverse events in elderly patients (65+)",
usage: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:acetaminophen+AND+serious:1+AND+patient.patientonsetage:[65+TO+*]",
"search_type": "adverse_events",
"limit": 40
}
},
{
description: "Find headache reactions in patients taking pain medications",
usage: {
"method": "lookup_drug",
"search_term": "patient.reaction.reactionmeddrapt:headache+AND+patient.drug.drugindication:pain",
"search_type": "adverse_events"
}
},
{
description: "Search serious Lipitor adverse events reported in the United States",
usage: {
"method": "lookup_drug",
"search_term": "occurcountry:US+AND+patient.drug.medicinalproduct:lipitor+AND+serious:1",
"search_type": "adverse_events",
"limit": 25
}
},
{
description: "Find non-serious adverse events for any of three antihistamines (grouped OR query)",
usage: {
"method": "lookup_drug",
"search_term": "(patient.drug.medicinalproduct:(cetirizine+OR+loratadine+OR+diphenhydramine))+AND+serious:2",
"search_type": "adverse_events"
}
},
{
description: "Search 2023 adverse event reports for female patients",
usage: {
"method": "lookup_drug",
"search_term": "receiptdate:[2023-01-01+TO+2023-12-31]+AND+patient.patientsex:2",
"search_type": "adverse_events",
"limit": 50
}
},
{
description: "Count adverse reactions for riluzole (population-level statistics)",
usage: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:riluzole",
"search_type": "adverse_events",
"count": "patient.reaction.reactionmeddrapt.exact",
"limit": 10
}
},
{
description: "Count serious vs non-serious adverse events across all drugs",
usage: {
"method": "lookup_drug",
"search_term": "*",
"search_type": "adverse_events",
"count": "serious",
"limit": 5
}
},
{
description: "Count adverse events by gender distribution",
usage: {
"method": "lookup_drug",
"search_term": "patient.drug.openfda.pharm_class_epc:\"nonsteroidal+anti-inflammatory+drug\"",
"search_type": "adverse_events",
"count": "patient.patientsex",
"limit": 5
}
},
{
description: "Count temporal patterns of adverse event reports by year",
usage: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:aspirin",
"search_type": "adverse_events",
"count": "receivedate",
"limit": 10
}
},
{
description: "Count adverse events by pharmacological class",
usage: {
"method": "lookup_drug",
"search_term": "*",
"search_type": "adverse_events",
"count": "patient.drug.openfda.pharm_class_epc",
"limit": 15
}
},
{
description: "Count adverse events by country of occurrence",
usage: {
"method": "lookup_drug",
"search_term": "serious:1",
"search_type": "adverse_events",
"count": "occurcountry",
"limit": 10
}
},
{
description: "Find all NSAID adverse events using pharmacological class",
usage: {
"method": "lookup_drug",
"search_term": "*",
"search_type": "adverse_events",
"pharm_class": "nonsteroidal anti-inflammatory drug",
"limit": 20
}
},
{
description: "Find aspirin adverse events within NSAID class",
usage: {
"method": "lookup_drug",
"search_term": "aspirin",
"search_type": "adverse_events",
"pharm_class": "nonsteroidal anti-inflammatory drug",
"limit": 15
}
},
{
description: "Find SSRI antidepressant adverse events",
usage: {
"method": "lookup_drug",
"search_term": "*",
"search_type": "adverse_events",
"pharm_class": "selective serotonin reuptake inhibitor",
"limit": 25
}
},
{
description: "Count serious adverse events by opioid pharmacological class",
usage: {
"method": "lookup_drug",
"search_term": "serious:1",
"search_type": "adverse_events",
"pharm_class": "opioid",
"count": "patient.reaction.reactionmeddrapt.exact",
"limit": 10
}
},
{
description: "Find beta blocker adverse events affecting cardiovascular system",
usage: {
"method": "lookup_drug",
"search_term": "patient.reaction.reactionmeddrapt:cardiovascular",
"search_type": "adverse_events",
"pharm_class": "beta blocker",
"limit": 15
}
},
{
description: "Find discontinued drug products",
usage: {
"method": "lookup_drug",
"search_term": "Discontinued",
"search_type": "general",
"fields_for_general": "products.marketing_status"
}
},
{
description: "Wildcard search for brand names containing 'MEF' pattern",
usage: {
"method": "lookup_drug",
"search_term": "MEF*",
"search_type": "general",
"fields_for_general": "openfda.brand_name"
}
},
{
description: "Wildcard search for products with '5' in any field (strength, NDC, etc.)",
usage: {
"method": "lookup_drug",
"search_term": "*5*",
"search_type": "general"
}
},
{
description: "Search by FDA application number (specific drug application)",
usage: {
"method": "lookup_drug",
"search_term": "NDA011459",
"search_type": "general",
"fields_for_general": "application_number"
}
},
{
description: "Find all drugs by a specific sponsor/company",
usage: {
"method": "lookup_drug",
"search_term": "PFIZER",
"search_type": "general",
"fields_for_general": "sponsor_name"
}
},
{
description: "Search for drugs by brand name (products level)",
usage: {
"method": "lookup_drug",
"search_term": "VISTARIL",
"search_type": "general",
"fields_for_general": "products.brand_name"
}
},
{
description: "Complex query: Find PFIZER capsules and tablets",
usage: {
"method": "lookup_drug",
"search_term": "(products.dosage_form:\"TABLET\"+OR+products.dosage_form:\"CAPSULE\")+AND+sponsor_name:\"PFIZER\"",
"search_type": "general",
"limit": 5
}
},
{
description: "Find adverse event reports that have seriousness information recorded",
usage: {
"method": "lookup_drug",
"search_term": "_exists_:serious",
"search_type": "adverse_events"
}
},
{
description: "Find prescription acetaminophen products (multi-field combination)",
usage: {
"method": "lookup_drug",
"search_term": "products.active_ingredients.name:acetaminophen+AND+products.marketing_status:prescription",
"search_type": "general",
"limit": 25
}
},
{
description: "Search drug recalls by recalling firm",
usage: {
"method": "lookup_drug",
"search_term": "Pfizer",
"search_type": "recalls",
"fields_for_recalls": "recalling_firm",
"limit": 10
}
},
{
description: "Find Class I recalls (most serious health hazard)",
usage: {
"method": "lookup_drug",
"search_term": "I",
"search_type": "recalls",
"fields_for_recalls": "classification",
"limit": 15
}
},
{
description: "Search recalls by product description",
usage: {
"method": "lookup_drug",
"search_term": "tablet",
"search_type": "recalls",
"fields_for_recalls": "product_description"
}
},
{
description: "Find voluntary vs mandated recalls",
usage: {
"method": "lookup_drug",
"search_term": "Voluntary",
"search_type": "recalls",
"fields_for_recalls": "voluntary_mandated"
}
},
{
description: "Search drug shortages by generic name",
usage: {
"method": "lookup_drug",
"search_term": "pravastatin",
"search_type": "shortages",
"fields_for_shortages": "generic_name"
}
},
{
description: "Find current drug shortages by status",
usage: {
"method": "lookup_drug",
"search_term": "Currently+in+Shortage",
"search_type": "shortages",
"fields_for_shortages": "status",
"limit": 20
}
},
{
description: "Search shortages by therapeutic category",
usage: {
"method": "lookup_drug",
"search_term": "CEPHALOSPORIN",
"search_type": "shortages",
"fields_for_shortages": "therapeutic_category"
}
},
{
description: "Find shortages by company name",
usage: {
"method": "lookup_drug",
"search_term": "Pfizer",
"search_type": "shortages",
"fields_for_shortages": "company_name"
}
},
{
description: "Search device registrations by product code",
usage: {
"method": "lookup_device",
"search_term": "HQY",
"search_type": "device_registration",
"fields_for_device_registration": "products.product_code",
"limit": 1
}
},
{
description: "Find devices by regulation number",
usage: {
"method": "lookup_device",
"search_term": "886.5850",
"search_type": "device_registration",
"fields_for_device_registration": "products.openfda.regulation_number",
"limit": 1
}
},
{
description: "Search device registrations by device class",
usage: {
"method": "lookup_device",
"search_term": "Class II",
"search_type": "device_registration",
"fields_for_device_registration": "products.openfda.device_class"
}
},
{
description: "Find device registrations by company name",
usage: {
"method": "lookup_device",
"search_term": "Abbott",
"search_type": "device_registration",
"fields_for_device_registration": "registration.name"
}
},
{
description: "Search approved PMA submissions by decision code",
usage: {
"method": "lookup_device",
"search_term": "APPR",
"search_type": "device_pma",
"fields_for_device_pma": "decision_code",
"limit": 1
}
},
{
description: "Find PMA records by product code",
usage: {
"method": "lookup_device",
"search_term": "LWP",
"search_type": "device_pma",
"fields_for_device_pma": "product_code",
"limit": 1
}
},
{
description: "Search PMA submissions by advisory committee",
usage: {
"method": "lookup_device",
"search_term": "EN",
"search_type": "device_pma",
"fields_for_device_pma": "advisory_committee"
}
},
{
description: "Find PMA submissions by applicant company",
usage: {
"method": "lookup_device",
"search_term": "Medtronic",
"search_type": "device_pma",
"fields_for_device_pma": "applicant"
}
},
{
description: "Search 510(k) clearances by cardiovascular advisory committee",
usage: {
"method": "lookup_device",
"search_term": "cv",
"search_type": "device_510k",
"fields_for_device_510k": "advisory_committee",
"limit": 1
}
},
{
description: "Find 510(k) clearances by regulation number",
usage: {
"method": "lookup_device",
"search_term": "868.5895",
"search_type": "device_510k",
"fields_for_device_510k": "openfda.regulation_number",
"limit": 1
}
},
{
description: "Search 510(k) clearances by device class",
usage: {
"method": "lookup_device",
"search_term": "Class II",
"search_type": "device_510k",
"fields_for_device_510k": "openfda.device_class"
}
},
{
description: "Find 510(k) clearances by applicant company",
usage: {
"method": "lookup_device",
"search_term": "Boston Scientific",
"search_type": "device_510k",
"fields_for_device_510k": "applicant"
}
},
{
description: "Search UDI database for records with public device record key",
usage: {
"method": "lookup_device",
"search_term": "_exists_:public_device_record_key",
"search_type": "device_udi",
"limit": 1
}
},
{
description: "Find UDI records with update status",
usage: {
"method": "lookup_device",
"search_term": "Update",
"search_type": "device_udi",
"fields_for_device_udi": "public_version_status",
"limit": 1
}
},
{
description: "Search UDI records by device class",
usage: {
"method": "lookup_device",
"search_term": "Class II",
"search_type": "device_udi",
"fields_for_device_udi": "product_codes.openfda.device_class"
}
},
{
description: "Find UDI records by company name",
usage: {
"method": "lookup_device",
"search_term": "Medtronic",
"search_type": "device_udi",
"fields_for_device_udi": "company_name"
}
},
{
description: "Search device recalls by classification",
usage: {
"method": "lookup_device",
"search_term": "Class II",
"search_type": "device_recalls",
"fields_for_device_recalls": "classification",
"limit": 5
}
},
{
description: "Find Class I device recalls (most serious)",
usage: {
"method": "lookup_device",
"search_term": "Class I",
"search_type": "device_recalls",
"fields_for_device_recalls": "classification",
"limit": 10
}
},
{
description: "Search device recalls by recalling firm",
usage: {
"method": "lookup_device",
"search_term": "Medtronic",
"search_type": "device_recalls",
"fields_for_device_recalls": "recalling_firm"
}
},
{
description: "Find voluntary vs mandated device recalls",
usage: {
"method": "lookup_device",
"search_term": "Voluntary",
"search_type": "device_recalls",
"fields_for_device_recalls": "voluntary_mandated"
}
},
{
description: "Search device adverse events for cardiac devices",
usage: {
"method": "lookup_device",
"search_term": "cardiac",
"search_type": "device_adverse_events",
"limit": 2
}
},
{
description: "Find device adverse events involving x-ray devices",
usage: {
"method": "lookup_device",
"search_term": "x-ray",
"search_type": "device_adverse_events",
"fields_for_device_adverse_events": "device.generic_name",
"limit": 1
}
},
{
description: "Search device adverse events by event type",
usage: {
"method": "lookup_device",
"search_term": "Injury",
"search_type": "device_adverse_events",
"fields_for_device_adverse_events": "event_type"
}
},
{
description: "Find device adverse events by manufacturer",
usage: {
"method": "lookup_device",
"search_term": "Medtronic",
"search_type": "device_adverse_events",
"fields_for_device_adverse_events": "manufacturer_name"
}
},
{
description: "Search device classification by regulation number",
usage: {
"method": "lookup_device",
"search_term": "872.6855",
"search_type": "device_classification",
"fields_for_device_classification": "regulation_number",
"limit": 1
}
},
{
description: "Find device classification by product code",
usage: {
"method": "lookup_device",
"search_term": "NOB",
"search_type": "device_classification",
"fields_for_device_classification": "product_code",
"limit": 1
}
},
{
description: "Search device classifications by device class",
usage: {
"method": "lookup_device",
"search_term": "Class II",
"search_type": "device_classification",
"fields_for_device_classification": "device_class"
}
},
{
description: "Find device classifications by medical specialty",
usage: {
"method": "lookup_device",
"search_term": "Radiology",
"search_type": "device_classification",
"fields_for_device_classification": "medical_specialty_description"
}
}
]
}
}
]
};
});
// Handle tool calls
server.setRequestHandler(CallToolRequestSchema, async (request) => {
const { name, arguments: args } = request.params;
if (name !== 'fda_info') {
throw new Error(`Unknown tool: ${name}`);
}
try {
const { method, search_term, search_type = 'general', fields_for_general, fields_for_adverse_events, fields_for_label, fields_for_recalls, fields_for_shortages, fields_for_device_registration, fields_for_device_pma, fields_for_device_510k, fields_for_device_udi, fields_for_device_recalls, fields_for_device_adverse_events, fields_for_device_classification, count, pharm_class, field_exists, limit = 10 } = args;
if (!search_term) {
throw new Error('search_term parameter is required');
}
switch (method) {
case 'lookup_drug': {
// Determine which field parameter to use based on search_type
let field = null;
if (search_type === 'adverse_events' && fields_for_adverse_events) {
field = fields_for_adverse_events;
} else if (search_type === 'label' && fields_for_label) {
field = fields_for_label;
} else if (search_type === 'recalls' && fields_for_recalls) {
field = fields_for_recalls;
} else if (search_type === 'shortages' && fields_for_shortages) {
field = fields_for_shortages;
} else if (search_type === 'general' && fields_for_general) {
field = fields_for_general;
}
const results = await lookupDrug(search_term, search_type, limit, field, count, pharm_class, field_exists);
return {
content: [
{
type: 'text',
text: JSON.stringify(results, null, 2)
}
]
};
}
case 'lookup_device': {
// Determine which field parameter to use based on search_type
let field = null;
if (search_type === 'device_registration' && fields_for_device_registration) {
field = fields_for_device_registration;
} else if (search_type === 'device_pma' && fields_for_device_pma) {
field = fields_for_device_pma;
} else if (search_type === 'device_510k' && fields_for_device_510k) {
field = fields_for_device_510k;
} else if (search_type === 'device_udi' && fields_for_device_udi) {
field = fields_for_device_udi;
} else if (search_type === 'device_recalls' && fields_for_device_recalls) {
field = fields_for_device_recalls;
} else if (search_type === 'device_adverse_events' && fields_for_device_adverse_events) {
field = fields_for_device_adverse_events;
} else if (search_type === 'device_classification' && fields_for_device_classification) {
field = fields_for_device_classification;
}
const results = await lookupDevice(search_term, search_type, limit, field);
return {
content: [
{
type: 'text',
text: JSON.stringify(results, null, 2)
}
]
};
}
default:
throw new Error(`Unknown method: ${method}`);
}
} catch (error) {
const errorMessage = error instanceof Error ? error.message : String(error);
return {
content: [
{
type: 'text',
text: JSON.stringify({
error: errorMessage,
success: false
}, null, 2)
}
]
};
}
});
// Register prompts using modern MCP SDK pattern
server.registerPrompt(
'drug_safety_analysis',
{
title: 'Drug Safety Analysis',
description: 'Comprehensive drug safety analysis using FDA adverse events data (FAERS database). Analyzes safety profile with total reports, top reactions, serious events by demographics, and age patterns for deaths.',
argsSchema: {
drug_name: {
type: 'string',
description: 'Name of the drug to analyze (generic or brand name)',
required: true
}
}
},
({ drug_name }) => {
const prompt = `Analyze the safety profile for ${drug_name} using FDA adverse events data with these optimized queries:
{
name: 'drug_safety_analysis',
description: 'Comprehensive drug safety analysis using FDA adverse events data (FAERS database). Analyzes safety profile with total reports, top reactions, serious events by demographics, and age patterns for deaths.',
arguments: [
{
name: 'drug_name',
description: 'Name of the drug to analyze (generic or brand name)',
required: true
}
]
},
{
name: 'pharmaceutical_competitive_intelligence',
description: 'Comprehensive pharmaceutical competitive intelligence analysis for company positioning, market share, portfolio strength, and strategic assessment using FDA regulatory data.',
arguments: [
{
name: 'company_name',
description: 'Name of the pharmaceutical company to analyze (sponsor name in FDA database)',
required: true
}
]
},
{
name: 'generic_competition_assessment',
description: 'Comprehensive generic competition assessment for Orange Book FDA analysis. Evaluates market entry patterns, competitive landscape, reference vs generic drug distinction, and market maturity indicators.',
arguments: [
{
name: 'brand_drug',
description: 'Brand name of the drug to analyze for generic competition (provide either brand_drug or generic_name)',
required: false
},
{
name: 'generic_name',
description: 'Generic name of the drug to analyze for generic competition (provide either brand_drug or generic_name)',
required: false
}
]
},
{
name: 'supply_chain_intelligence',
description: 'Comprehensive supply chain risk assessment for drug manufacturing and availability. Analyzes current shortages, therapeutic vulnerability patterns, supplier concentration risks, and manufacturing resilience.',
arguments: [
{
name: 'drug_name',
description: 'Specific drug name (generic) to analyze for supply chain risks (provide either drug_name or therapeutic_area)',
required: false
},
{
name: 'therapeutic_area',
description: 'Therapeutic area to analyze (e.g., "Oncology", "Cardiovascular", "Pediatric") (provide either drug_name or therapeutic_area)',
required: false
}
]
},
{
name: 'fda_regulatory_intelligence',
description: 'Comprehensive FDA regulatory intelligence analysis combining approval timeline, safety surveillance, recent regulatory activity, and supply chain status for drugs or companies.',
arguments: [
{
name: 'drug_name',
description: 'Drug name (brand or generic) to analyze for regulatory intelligence (provide either drug_name or company_name)',
required: false
},
{
name: 'company_name',
description: 'Pharmaceutical company name to analyze for regulatory intelligence (provide either drug_name or company_name)',
required: false
}
]
},
{
name: 'weekly_regulatory_monitoring',
description: 'Automated weekly pharmaceutical regulatory intelligence report with surveillance queries for monitoring regulatory activity, safety signals, and supply chain intelligence.',
arguments: [
{
name: 'target_entity',
description: 'Company name, drug name, or therapeutic area to monitor (e.g., "Pfizer", "metformin", "Oncology")',
required: true
},
{
name: 'current_date',
description: 'Current date in YYYY-MM-DD format for date range calculations (e.g., "2024-09-17")',
required: true
}
]
},
{
name: 'fda_market_intelligence',
description: 'FDA-focused market intelligence analysis including patent protection timelines, generic competition risks, and regulatory pathway impacts on market access for investment decision-making.',
arguments: [
{
name: 'drug_name',
description: 'Drug name (brand or generic) for market intelligence analysis (provide either drug_name or company_name)',
required: false
},
{
name: 'company_name',
description: 'Pharmaceutical company name for market intelligence analysis (provide either drug_name or company_name)',
required: false
}
]
}
]
};
});
// Handle prompt requests
server.setRequestHandler(GetPromptRequestSchema, async (request) => {
const { name, arguments: args } = request.params;
if (name === 'drug_safety_analysis') {
const drugName = args?.drug_name;
if (!drugName) {
throw new Error('drug_name argument is required');
}
const prompt = `Analyze the safety profile for ${drugName} using FDA adverse events data with these optimized queries:
1. Total reports with reaction data:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:\\"${drugName}\\"",
"search_type": "adverse_events",
"field_exists": "patient.reaction.reactionmeddrapt",
"limit": 1
}
2. Top adverse reactions (count statistics):
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:\\"${drugName}\\"",
"search_type": "adverse_events",
"count": "patient.reaction.reactionmeddrapt.exact",
"limit": 10
}
3. Serious events by gender demographics:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:\\"${drugName}\\"+AND+serious:1",
"search_type": "adverse_events",
"count": "patient.patientsex",
"limit": 5
}
4. Death events by age patterns:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:\\"${drugName}\\"+AND+seriousnessdeath:1",
"search_type": "adverse_events",
"count": "patient.patientonsetage",
"limit": 8
}
**Analysis Guidelines:**
- Sex codes: 1=male, 2=female, 0=unknown
- Focus on count statistics for population-level insights, not individual cases
- Look for patterns in age demographics and serious event rates
- Consider reaction frequency and severity
**Output Format:**
1. **Safety Overview** (2 bullets): Total reports summary and data completeness
2. **Top Reactions Table**: Most frequent adverse events with counts
3. **Demographics Summary**: Gender distribution and age patterns for serious events
4. **Risk Assessment** (1 paragraph): Key safety signals and clinical implications
Execute these queries in sequence and provide a comprehensive safety analysis based on the FDA adverse events data.`;
return {
description: `Drug safety analysis for ${drugName} using FDA FAERS database`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: prompt
}
}
]
};
} else if (name === 'pharmaceutical_competitive_intelligence') {
const companyName = args?.company_name;
if (!companyName) {
throw new Error('company_name argument is required');
}
const prompt = `Analyze ${companyName}'s competitive position in the pharmaceutical market using FDA regulatory data with these strategic queries:
1. Rank top pharmaceutical companies by prescription drug applications:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "products.marketing_status:Prescription",
"search_type": "general",
"count": "sponsor_name",
"limit": 10
}
2. Company's position among pharmaceutical competitors with active prescription products:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "sponsor_name:\\"${companyName}\\" AND products.marketing_status:Prescription",
"search_type": "general",
"count": "application_number",
"limit": 15
}
3. Company's top active prescription brands and generic names:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "sponsor_name:\\"${companyName}\\" AND products.marketing_status:Prescription",
"search_type": "general",
"fields_for_general": "openfda.brand_name",
"limit": 15
}
4. Company's formulation specializations and delivery methods:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "sponsor_name:\\"${companyName}\\" AND products.marketing_status:Prescription",
"search_type": "general",
"fields_for_general": "products.dosage_form",
"limit": 10
}
5. Company's latest regulatory submissions and pipeline products:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "sponsor_name:\\"${companyName}\\"",
"search_type": "general",
"fields_for_general": "application_number",
"limit": 10
}
**Analysis Framework:**
- **Market Position**: Rank vs top 8 sponsors by application volume
- **Portfolio Strength**: Active prescription drugs vs discontinued products
- **Regulatory Momentum**: Recent approvals/submissions in past 2 years
- **Competitive Focus**: Dosage form specialization and therapeutic class concentration
**Output Format:**
1. **Market Position** (3 bullets): Ranking, relative size, competitive tier
2. **Portfolio Summary** (table): Top 5-7 products with status and approval dates
3. **Strategic Assessment** (1 paragraph): Regulatory activity, dosage focus, competitive advantages
Execute these queries in sequence and provide a comprehensive competitive intelligence analysis based on the FDA regulatory data.`;
return {
description: `Pharmaceutical competitive intelligence analysis for ${companyName} using FDA regulatory data`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: prompt
}
}
]
};
} else if (name === 'generic_competition_assessment') {
const brandDrug = args?.brand_drug;
const genericName = args?.generic_name;
if (!brandDrug && !genericName) {
throw new Error('Either brand_drug or generic_name argument is required');
}
const drugIdentifier = brandDrug || genericName;
const providedType = brandDrug ? 'brand' : 'generic';
const prompt = `Assess generic competition for ${drugIdentifier} using Orange Book FDA analysis with these targeted queries:
1. Confirm drug details and derive missing information:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${brandDrug ? `products.brand_name:\\"${brandDrug}\\"` : `openfda.generic_name:\\"${genericName}\\"`}",
"search_type": "general",
"fields_for_general": "openfda.brand_name,openfda.generic_name,sponsor_name,application_number",
"limit": 1
}
Note: From the result above, use the derived generic name for subsequent queries (queries 2-5 should use the generic name found in openfda.generic_name field).
2. Total competitive landscape including originator + generics:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "openfda.generic_name:[DERIVED_GENERIC_NAME] AND products.marketing_status:Prescription",
"search_type": "general",
"count": "sponsor_name",
"limit": 8
}
3. Reference vs generic drug distinction:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "openfda.generic_name:[DERIVED_GENERIC_NAME] AND products.marketing_status:Prescription",
"search_type": "general",
"fields_for_general": "sponsor_name,products.reference_drug",
"limit": 5
}
4. Latest generic entries (non-reference drugs):
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "openfda.generic_name:[DERIVED_GENERIC_NAME] AND products.reference_drug:No",
"search_type": "general",
"fields_for_general": "sponsor_name,application_number",
"limit": 3
}
5. Market timeline and chronological approvals:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "openfda.generic_name:[DERIVED_GENERIC_NAME] AND products.marketing_status:Prescription",
"search_type": "general",
"fields_for_general": "sponsor_name,products.reference_drug",
"limit": 3
}
**Analysis Framework:**
- **Market Maturity**: Reference drug vs generic manufacturer count
- **Competitive Intensity**: Number of approved biosimilars/generics
- **Entry Momentum**: Recent approval timeline and sponsor diversity
- **Market Accessibility**: Patent cliff indicators and exclusivity status
**Output Format:**
1. **Competition Status** (3 bullets): Total manufacturers, originator vs generics, market maturity
2. **Competitive Timeline** (table): Chronological approvals with sponsor and application numbers
3. **Market Assessment** (1 paragraph): Competition intensity, recent entries, strategic implications
Execute these queries in sequence and provide a comprehensive generic competition assessment based on the Orange Book FDA analysis.`;
return {
description: `Generic competition assessment for ${drugIdentifier} (${providedType} name provided) using Orange Book FDA analysis`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: prompt
}
}
]
};
} else if (name === 'supply_chain_intelligence') {
const drugName = args?.drug_name;
const therapeuticArea = args?.therapeutic_area;
if (!drugName && !therapeuticArea) {
throw new Error('Either drug_name or therapeutic_area argument is required');
}
const analysisTarget = drugName || therapeuticArea;
const providedType = drugName ? 'drug' : 'therapeutic_area';
let prompt;
if (therapeuticArea) {
prompt = `Analyze supply chain risks for ${therapeuticArea} therapeutic area with these optimized queries:
1. Active shortages in ${therapeuticArea} therapeutic area:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "therapeutic_category:\\"${therapeuticArea}\\"",
"search_type": "shortages",
"fields_for_shortages": "generic_name,company_name,status,shortage_reason",
"limit": 5
}
2. Shortage patterns by therapeutic category:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "status:Current",
"search_type": "shortages",
"count": "therapeutic_category",
"limit": 8
}
3. Companies affected in ${therapeuticArea} area:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "therapeutic_category:\\"${therapeuticArea}\\" AND status:Current",
"search_type": "shortages",
"fields_for_shortages": "company_name",
"limit": 5
}
4. Shortage reasons in ${therapeuticArea} category:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "therapeutic_category:\\"${therapeuticArea}\\"",
"search_type": "shortages",
"fields_for_shortages": "shortage_reason",
"limit": 5
}
5. Upcoming supply exits (discontinuation risk):
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "status:\\"To Be Discontinued\\"",
"search_type": "shortages",
"fields_for_shortages": "generic_name,company_name,discontinued_date",
"limit": 3
}`;
} else {
prompt = `Analyze supply chain risks for ${drugName} drug with these optimized queries:
1. Derive therapeutic area and current shortage status for ${drugName}:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "generic_name:\\"${drugName}\\"",
"search_type": "shortages",
"fields_for_shortages": "therapeutic_category,status,shortage_reason,company_name",
"limit": 5
}
Note: From the result above, use the derived therapeutic_category for subsequent therapeutic area analysis.
2. Market concentration risk for ${drugName}:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "openfda.generic_name:\\"${drugName}\\" AND products.marketing_status:Prescription",
"search_type": "general",
"count": "sponsor_name",
"limit": 5
}
3. Manufacturing diversity for ${drugName} formulations:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "openfda.generic_name:\\"${drugName}\\" AND products.marketing_status:Prescription",
"search_type": "general",
"fields_for_general": "products.dosage_form,products.route",
"limit": 5
}
4. Supplier manufacturers for ${drugName}:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "openfda.generic_name:\\"${drugName}\\" AND products.marketing_status:Prescription",
"search_type": "general",
"fields_for_general": "sponsor_name",
"limit": 8
}
5. Therapeutic area shortage patterns (use derived category from query 1):
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "therapeutic_category:[DERIVED_THERAPEUTIC_CATEGORY] AND status:Current",
"search_type": "shortages",
"fields_for_shortages": "generic_name,company_name,shortage_reason",
"limit": 5
}`;
}
prompt += `
**Critical Parameter Guidelines:**
- Therapeutic categories are case-sensitive (use "Oncology", "Pediatric", "Cardiovascular")
- Quote multi-word status values: status:"To Be Discontinued"
- Use status:Current for active shortages (wildcards don't work for shortages)
**Analysis Framework:**
- **Active Disruptions**: Current shortages and their root causes
- **Therapeutic Vulnerability**: Categories most prone to shortages
- **Supply Concentration**: Single vs multi-supplier dependency
- **Manufacturing Resilience**: Formulation and delivery redundancy
**Output Format:**
1. **Current Supply Status** (3 bullets): Active shortages, primary causes, affected categories
2. **Risk Assessment** (table): Supplier concentration and vulnerability metrics
3. **Mitigation Strategy** (1 paragraph): Supply chain diversification and contingency recommendations
Execute these queries in sequence and provide a comprehensive supply chain risk assessment.`;
return {
description: `Supply chain intelligence analysis for ${analysisTarget} (${providedType} provided)`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: prompt
}
}
]
};
} else if (name === 'fda_regulatory_intelligence') {
const drugName = args?.drug_name;
const companyName = args?.company_name;
if (!drugName && !companyName) {
throw new Error('Either drug_name or company_name argument is required');
}
const analysisTarget = drugName || companyName;
const providedType = drugName ? 'drug' : 'company';
let prompt;
if (drugName) {
prompt = `Conduct comprehensive regulatory analysis for ${drugName} with these intelligence queries:
1. Core approval details and derive missing information:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${drugName.toLowerCase().includes('brand') || /^[A-Z]/.test(drugName) ? `products.brand_name:\\"${drugName}\\"` : `openfda.generic_name:\\"${drugName}\\"`}",
"search_type": "general",
"fields_for_general": "application_number,sponsor_name,openfda.brand_name,openfda.generic_name,products.marketing_status,submissions.submission_type,submissions.submission_status,submissions.submission_class_code,submissions.submission_status_date",
"limit": 1
}
Note: From the result above, use the derived generic name (openfda.generic_name) and application number for subsequent queries.
2. Safety surveillance profile from adverse events:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:[DERIVED_GENERIC_NAME]",
"search_type": "adverse_events",
"count": "patient.reaction.reactionmeddrapt.exact",
"limit": 8
}
3. Serious adverse events by demographics:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.medicinalproduct:[DERIVED_GENERIC_NAME]+AND+serious:1",
"search_type": "adverse_events",
"count": "patient.patientsex",
"limit": 5
}
4. Recent regulatory activity and submissions:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "application_number:[DERIVED_APPLICATION_NUMBER]",
"search_type": "general",
"fields_for_general": "submissions.submission_type,submissions.submission_status,submissions.submission_class_code,submissions.submission_status_date",
"limit": 5
}
5. Current supply chain status:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "generic_name:[DERIVED_GENERIC_NAME]",
"search_type": "shortages",
"fields_for_shortages": "status,shortage_reason,update_date",
"limit": 3
}`;
} else {
prompt = `Conduct comprehensive regulatory analysis for ${companyName} with these intelligence queries:
1. Company's drug portfolio and derive specific products:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "sponsor_name:\\"${companyName}\\" AND products.marketing_status:Prescription",
"search_type": "general",
"fields_for_general": "application_number,openfda.brand_name,openfda.generic_name,products.marketing_status,submissions.submission_type,submissions.submission_status,submissions.submission_status_date",
"limit": 10
}
Note: From the result above, select key products for detailed analysis in subsequent queries.
2. Company's recent regulatory submissions:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "sponsor_name:\\"${companyName}\\"",
"search_type": "general",
"fields_for_general": "submissions.submission_type,submissions.submission_status,submissions.submission_class_code,submissions.submission_status_date",
"limit": 10
}
3. Safety surveillance for company's portfolio:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "patient.drug.openfda.manufacturer_name:\\"${companyName}\\"",
"search_type": "adverse_events",
"count": "patient.reaction.reactionmeddrapt.exact",
"limit": 8
}
4. Company's supply chain disruptions:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "company_name:\\"${companyName}\\"",
"search_type": "shortages",
"fields_for_shortages": "generic_name,status,shortage_reason,update_date",
"limit": 5
}
5. Market position and competitive analysis:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "sponsor_name:\\"${companyName}\\" AND products.marketing_status:Prescription",
"search_type": "general",
"count": "openfda.product_type",
"limit": 5
}`;
}
prompt += `
**Analysis Framework:**
- **Regulatory Pathway**: Original approval date, submission history, review classifications
- **Safety Surveillance**: Top adverse events, serious event patterns, demographic risks
- **Current Status**: Recent submissions, labeling changes, ongoing regulatory actions
- **Supply Security**: Manufacturing disruptions, shortage risks, regulatory interventions
**Output Format:**
1. **Regulatory Timeline** (table): Key approval milestones and submission history
2. **Safety Profile** (3 bullets): Top adverse events, serious event rates, risk demographics
3. **Current Status** (2 bullets): Recent regulatory activity and ongoing actions
Execute these queries in sequence and provide a comprehensive FDA regulatory intelligence analysis.`;
return {
description: `FDA regulatory intelligence analysis for ${analysisTarget} (${providedType} provided)`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: prompt
}
}
]
};
} else if (name === 'weekly_regulatory_monitoring') {
const targetEntity = args?.target_entity;
const currentDate = args?.current_date;
if (!targetEntity) {
throw new Error('target_entity argument is required');
}
if (!currentDate) {
throw new Error('current_date argument is required');
}
// Calculate date ranges - use 3 weeks ago for monitoring (2-3 week FDA processing delay)
const current = new Date(currentDate);
const threeWeeksAgo = new Date(current);
threeWeeksAgo.setDate(current.getDate() - 21);
// Get Monday of that week
const lastWeekStart = new Date(threeWeeksAgo);
lastWeekStart.setDate(threeWeeksAgo.getDate() - threeWeeksAgo.getDay() + 1);
// Get Sunday of that week
const lastWeekEnd = new Date(lastWeekStart);
lastWeekEnd.setDate(lastWeekStart.getDate() + 6);
// Format as YYYYMMDD
const formatDate = (date) => {
return date.getFullYear().toString() +
(date.getMonth() + 1).toString().padStart(2, '0') +
date.getDate().toString().padStart(2, '0');
};
const lastWeekStartFormatted = formatDate(lastWeekStart);
const lastWeekEndFormatted = formatDate(lastWeekEnd);
const prompt = `Today is ${currentDate}. Create automated weekly monitoring for ${targetEntity} with these surveillance queries (using data from ${lastWeekStartFormatted} to ${lastWeekEndFormatted} accounting for FDA processing delay):
**1. Core Regulatory Intelligence** (3 queries)
1.1. Weekly regulatory activity:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "submissions.submission_status_date:[${lastWeekStartFormatted}+TO+${lastWeekEndFormatted}]",
"search_type": "general",
"fields_for_general": "sponsor_name,openfda.brand_name,submissions.submission_class_code,submissions.submission_status_date",
"limit": 10
}
1.2. Priority review pipeline:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "submissions.review_priority:\\"PRIORITY\\"",
"search_type": "general",
"fields_for_general": "sponsor_name,openfda.brand_name,submissions.submission_class_code,submissions.submission_status_date",
"limit": 8
}
1.3. Target entity focus:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "sponsor_name:\\"${targetEntity}\\" OR openfda.generic_name:\\"${targetEntity}\\" OR openfda.pharm_class_epc:\\"${targetEntity}\\"",
"search_type": "general",
"fields_for_general": "sponsor_name,openfda.brand_name,submissions.submission_type,submissions.submission_status_date",
"limit": 10
}
**2. Safety Intelligence** (2 queries)
2.1. Weekly adverse events:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "receivedate:[${lastWeekStartFormatted}+TO+${lastWeekEndFormatted}]",
"search_type": "adverse_events",
"count": "patient.drug.medicinalproduct.exact",
"limit": 10
}
2.2. Targeted safety signals:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "(patient.drug.medicinalproduct:\\"${targetEntity}\\" OR patient.drug.openfda.brand_name:\\"${targetEntity}\\") AND serious:1 AND receivedate:[${lastWeekStartFormatted}+TO+${lastWeekEndFormatted}]",
"search_type": "adverse_events",
"count": "patient.reaction.reactionmeddrapt.exact",
"limit": 8
}
**3. Supply Chain Intelligence** (1 query)
3.1. Targeted shortages:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "status:\\"Current\\" AND (generic_name:\\"${targetEntity}\\" OR company_name:\\"${targetEntity}\\")",
"search_type": "shortages",
"fields_for_shortages": "generic_name,company_name,shortage_reason,update_date",
"limit": 10
}
**Date Range Calculation Details:**
- Current date: ${currentDate}
- Monitoring period: ${lastWeekStartFormatted} to ${lastWeekEndFormatted} (3 weeks ago)
- Processing delay: Accounts for 2-3 week FDA data processing delay
- Format: YYYYMMDD (Year-Month-Day with no separators)
**Output Format:**
1. **Executive Summary** (3 bullet points): Key developments, emerging risks, competitive threats
2. **Regulatory Activity Table**: New approvals, submissions, status changes with dates
3. **Safety Alerts** (2 bullet points): Notable adverse event patterns, regulatory communications
4. **Strategic Implications** (1 paragraph): Impact assessment and recommended actions
Format as readable bullet points and paragraphs, not as JSON or structured data.
Execute these queries in sequence and provide a comprehensive weekly pharmaceutical regulatory intelligence report.`;
return {
description: `Weekly regulatory monitoring report for ${targetEntity} (period: ${lastWeekStartFormatted}-${lastWeekEndFormatted})`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: prompt
}
}
]
};
} else if (name === 'fda_market_intelligence') {
const drugName = args?.drug_name;
const companyName = args?.company_name;
if (!drugName && !companyName) {
throw new Error('Either drug_name or company_name argument is required');
}
const analysisTarget = drugName || companyName;
const providedType = drugName ? 'drug' : 'company';
let prompt;
if (drugName) {
prompt = `Generate FDA-focused market intelligence for ${drugName} with these regulatory queries:
1. Derive complete drug information and application details:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "${drugName.toLowerCase().includes('brand') || /^[A-Z]/.test(drugName) ? `products.brand_name:\\"${drugName}\\"` : `openfda.generic_name:\\"${drugName}\\"`}",
"search_type": "general",
"fields_for_general": "application_number,sponsor_name,openfda.brand_name,openfda.generic_name,products.te_code,products.marketing_status",
"limit": 1
}
Note: From the result above, use the derived application_number and generic_name for subsequent analyses.
2. Patent protection and exclusivity timeline:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "application_number:[DERIVED_APPLICATION_NUMBER]",
"search_type": "general",
"fields_for_general": "application_number,products.te_code,openfda.brand_name,openfda.generic_name,products.marketing_status,submissions.submission_class_code,submissions.submission_status_date",
"limit": 5
}
3. Generic competition market entry risk assessment:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "openfda.generic_name:[DERIVED_GENERIC_NAME] AND products.marketing_status:Prescription",
"search_type": "general",
"count": "sponsor_name",
"limit": 10
}
4. Competitive landscape and reference drug status:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "openfda.generic_name:[DERIVED_GENERIC_NAME] AND products.marketing_status:Prescription",
"search_type": "general",
"fields_for_general": "sponsor_name,products.reference_drug,products.te_code",
"limit": 8
}
5. Regulatory pathway impact on market access:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "openfda.brand_name:[DERIVED_BRAND_NAME]",
"search_type": "general",
"fields_for_general": "submissions.submission_class_code,submissions.submission_status,submissions.submission_status_date,products.marketing_status,submissions.review_priority",
"limit": 5
}`;
} else {
prompt = `Generate FDA-focused market intelligence for ${companyName} with these regulatory queries:
1. Company portfolio and market positioning:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "sponsor_name:\\"${companyName}\\" AND products.marketing_status:Prescription",
"search_type": "general",
"fields_for_general": "application_number,openfda.brand_name,openfda.generic_name,products.te_code,products.marketing_status,submissions.submission_class_code",
"limit": 15
}
2. Patent cliff analysis across portfolio:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "sponsor_name:\\"${companyName}\\" AND products.marketing_status:Prescription",
"search_type": "general",
"fields_for_general": "openfda.brand_name,openfda.generic_name,products.te_code,submissions.submission_status_date",
"limit": 10
}
3. Generic competition exposure across key products:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "sponsor_name:\\"${companyName}\\" AND products.marketing_status:Prescription AND products.reference_drug:Yes",
"search_type": "general",
"fields_for_general": "openfda.brand_name,openfda.generic_name,products.te_code",
"limit": 8
}
4. Regulatory pathway advantages and breakthrough designations:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "sponsor_name:\\"${companyName}\\" AND (submissions.review_priority:\\"PRIORITY\\" OR submissions.submission_class_code:\\"BLA\\")",
"search_type": "general",
"fields_for_general": "openfda.brand_name,submissions.submission_class_code,submissions.review_priority,submissions.submission_status_date",
"limit": 8
}
5. Market access and competitive moats assessment:
- Tool: fda_info
- Parameters: {
"method": "lookup_drug",
"search_term": "sponsor_name:\\"${companyName}\\" AND products.marketing_status:Prescription",
"search_type": "general",
"count": "products.te_code",
"limit": 5
}`;
}
prompt += `
**FDA Market Intelligence Analysis Framework:**
- **Patent Cliff Analysis**: Exclusivity timeline, TE codes, generic entry risk assessment
- **Competitive Moats**: Reference drug status, regulatory barriers, submission classifications
- **Market Positioning**: Priority review designations, breakthrough therapy status, approval pathways
- **Investment Risk Assessment**: Generic competition timeline, regulatory advantage duration
**Output Format:**
1. **Patent Protection Status** (table): TE codes, exclusivity indicators, reference drug status
2. **Competitive Moats** (3 bullets): Patent protection, regulatory barriers, market positioning advantages
3. **Investment Risk Assessment** (1 paragraph): Generic entry timeline, competitive threats, regulatory catalyst opportunities
Execute these queries in sequence and provide FDA-focused market intelligence for investment decision-making.`;
return {
description: `FDA market intelligence analysis for ${analysisTarget} (${providedType} provided)`,
messages: [
{
role: 'user',
content: {
type: 'text',
text: prompt
}
}
]
};
} else {
throw new Error(`Unknown prompt: ${name}`);
}
});
// Start the server
async function main() {
const transport = new StdioServerTransport();
await server.connect(transport);
// Log to stderr so it doesn't interfere with JSON-RPC
process.stderr.write('FDA MCP server running on stdio\n');
}
main().catch((error) => {
process.stderr.write(`Server error: ${error}\n`);
process.exit(1);
});
