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Openfda

by io.github.pipeworx-io
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Fda Novel Approvals

fda_novel_approvals
Read-onlyIdempotent

Most recent NOVEL drug approvals, in FDA/CDER's own sense of the word: a new drug or biologic never before approved or marketed in the U.S. (read live from FDA's own published Novel Drug Approvals list). Use for "what is the most recent novel drug the FDA approved", "how many novel drugs has CDER approved this year", "latest FDA drug approvals". Excludes generics, reformulations of an already-approved ingredient, and biosimilars — these are NOT on FDA's novel list even though they are "original" NDA/BLA submissions. Returns approval date, drug name, active ingredient, and approved use, sorted newest-first; application numbers/sponsors are not published on FDA's novel-drug page. Pass include_generics:true for a different, broader count (every original NDA/BLA/ANDA approval reconstructed from Drugs@FDA, reformulations/biosimilars included) — that path says so in its own note. Not for label text (fda_drug_labels) or searching a specific known drug (fda_drug_approvals).

Input Schema

NameRequiredDescriptionDefault
daysNoLook-back window in days (1-365, default 90)
skipNoOffset into the newest-first results (default 0). total_in_window can exceed the 50-result cap on one call — pass skip=50 to page further into the window instead of assuming the window is fully covered.
limitNoMax approvals to return (1-50, default 10)
include_genericsNoWhen true, switch from FDA's own novel-drug list to a broader Drugs@FDA reconstruction that also includes original ANDA (generic) approvals, reformulations, and biosimilars (default false — the default is FDA's own "novel" list, which excludes all of those).

Schema Changelog

Changes observed during successful MCP inspections.

  1. Changed1 schema field changed
    • changedInput schema / properties / include_generics / description
      Previous value: -"Also include original ANDA (generic) approvals (default false — novel means NDA/BLA only)"New value: +"When true, switch from FDA's own novel-drug list to a broader Drugs@FDA reconstruction that also includes original ANDA (generic) approvals, reformulations, and biosimilars (default false — the default is FDA's own \"novel\" list, which excludes all of those)."
  2. Changed1 schema field changed
    • addedInput schema / properties / skip
      Added value: +{
+  "description": "Offset into the newest-first results (default 0). total_in_window can exceed the 50-result cap on one call — pass skip=50 to page further into the window instead of assuming the window is fully covered.",
+  "type": "number"
+}
  3. Changed1 schema field changed
    • addedInput schema / examples
      Added value: +[
+  {
+    "days": 90,
+    "limit": 10
+  },
+  {
+    "days": 30,
+    "include_generics": false,
+    "limit": 5
+  }
+]
  4. Added

TDQS

A4.6/5.0
Behavior5/5

Does the description disclose side effects, auth requirements, rate limits, or destructive behavior?

Annotations already cover safety profile: read-only, idempotent, open-world, non-destructive. The description adds substantial context beyond that: it reads live from FDA's published Novel Drug Approvals list, excludes generics/reformulations/biosimilars, returns newest-first, lists returned fields, and notes that application numbers and sponsors are not published on that page.

Agents need to know what a tool does to the world before calling it. Descriptions should go beyond structured annotations to explain consequences.

Conciseness4/5

Is the description appropriately sized, front-loaded, and free of redundancy?

The information is front-loaded and nearly every sentence serves routing, exclusion, or output clarity. It is long for a description, and the meta-comment that the broader path 'says so in its own note' adds slight bulk, but overall it is dense rather than padded.

Shorter descriptions cost fewer tokens and are easier for agents to parse. Every sentence should earn its place.

Completeness5/5

Given the tool's complexity, does the description cover enough for an agent to succeed on first attempt?

No output schema exists, so the description carries the burden of explaining return shape: approval date, drug name, active ingredient, approved use, sorted newest-first. It also covers the major behavioral caveats and alternative modes, leaving an agent with enough information to invoke the tool correctly.

Complex tools with many parameters or behaviors need more documentation. Simple tools need less. This dimension scales expectations accordingly.

Parameters3/5

Does the description clarify parameter syntax, constraints, interactions, or defaults beyond what the schema provides?

Schema description coverage is 100%, so days, skip, limit, and include_generics are already fully documented in the input schema. The description reinforces include_generics as a broader Drugs@FDA reconstruction path, but adds little semantic detail beyond what the schema already states.

Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.

Purpose5/5

Does the description clearly state what the tool does and how it differs from similar tools?

States a specific verb and resource: 'Most recent NOVEL drug approvals,' then defines FDA/CDER's own sense of novel as never before approved or marketed in the U.S. It explicitly distinguishes this from generics, reformulations, and biosimilars, and names sibling tools for adjacent needs.

Agents choose between tools based on descriptions. A clear purpose with a specific verb and resource helps agents select the right tool.

Usage Guidelines5/5

Does the description explain when to use this tool, when not to, or what alternatives exist?

Gives explicit use cases such as 'what is the most recent novel drug the FDA approved' and 'how many novel drugs has CDER approved this year.' It states exclusions, explains the include_generics alternative, and ends with clear when-not-to-use routing to fda_drug_labels and fda_drug_approvals.

Agents often have multiple tools that could apply. Explicit usage guidance like "use X instead of Y when Z" prevents misuse.

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