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fda-approvals-mcp — SCAFFOLD

Drug approvals, device clearances (510(k)), recalls, adverse events. Wraps the openFDA free API. Sister product to sec-edgar-mcp — same patterns, biotech audience instead of finance.

Status: scaffolded. Idea #4 in ../../../ai-as-customer-ideas.md.


Planned tools

Tool

openFDA endpoint

Notes

fda_drug_approval_search(date_range, sponsor?, indication?)

/drug/drugsfda.json

New drug approvals (NDA/BLA).

fda_drug_label(drug_name)

/drug/label.json

Full drug label text.

fda_recall_search(class?, date_range)

/drug/enforcement.json, /device/enforcement.json

Class I/II/III recall events.

fda_adverse_events(drug_name, date_range)

/drug/event.json

FAERS adverse event reports — count + breakdown.

fda_510k_search(date_range, sponsor?)

/device/510k.json

Premium tier: device 510(k) clearances.

fda_drug_shortages()

drug shortage list

Premium.

Related MCP server: Unofficial FDA MCP Server

Audience

  • Clinical-LLM teams (Hippocratic, Glass, OpenEvidence, AmazeVet, Scribeberry).

  • Pharma research analysts.

  • Biotech / pharma investor agents (cross-sells with sec-edgar-mcp).

  • Journalists covering pharma.

Pricing (proposed)

Same tier shape as SEC EDGAR. Slightly higher willingness-to-pay in pharma → bias toward Team/Pro upsells.

Open / closed split

  • Open: MCP shim, openFDA wrapper (it's literally a public API; no moat).

  • Closed: alerts/subscriptions, drug-name normalization (RxNorm cross-ref), de-duplication of FAERS reports (multiple reporters per event), enriched label parsing.

Build steps

Same as SEC EDGAR. openFDA is even cleaner than EDGAR — JSON-RPC-compatible payloads, no User-Agent gymnastics, generous rate limits.

See also


Sister MCPs

All from the same operator, all live on <product>.prakhar-cognizance.workers.dev, all free-tier friendly:

Full catalog: https://github.com/guptaprakhariitr · ⭐ = empty-quadrant / highest-conviction pick.

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license - not found
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quality - not tested
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maintenance

Maintenance

Maintainers
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Release cycle
Releases (12mo)
Commit activity

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