FDA applications and reviews

Overview

Four FDA datasets follow a drug through review:

Drug applications: every NDA, ANDA (generic) and BLA FDA lists, one record per application, with the sponsor linked to a Pav company where possible, and the full dossier of FDA records and submissions on it.
Complete response letters: the letters FDA sends when it will not approve an application as submitted, one per letter, linked to the letter PDF.
Accelerated approvals: one record per product and approved indication, with the confirmatory requirements and whether they were verified.
Advisory committee meetings: FDA’s advisory committee calendar, past and scheduled, with the materials FDA posted.

Each is also a record_type on GET /v1/fda and shares its fields. Questions these datasets answer:

Which applications has a company had approved, and what did FDA act on most recently?
Which drugs received a complete response letter this year?
Which accelerated approvals still have confirmatory trials pending?
When does the Oncologic Drugs Advisory Committee next meet?

Coverage

Dataset	Records (September 2026)	Linked to a Pav company
Drug applications	29,359	68%
Complete response letters	365	87%
Accelerated approvals	370	59%
Advisory committee meetings	556	Meetings name no company

Endpoints

Endpoint	Use
`GET /v1/fda/applications`	List and search drug applications.
`GET /v1/fda/applications/{application_key}`	One application with every FDA record on it and its submissions.
`GET /v1/fda/complete-response-letters`	List complete response letters.
`GET /v1/fda/accelerated-approvals`	List accelerated approvals.
`GET /v1/fda/advisory-committee-meetings`	List advisory committee meetings.

Filters

The four list endpoints take the same filters.

Parameter	Matches	Example
`q`	Case-insensitive substring of the title, description, company name or an FDA identifier.	`oncologic`
`company_id`	Records linked to these Pav companies or the companies they own. Repeatable.	`218`
`application_key`	Exact FDA application: `N:` (NDA), `A:` (ANDA) or `BLA:` plus the number.	`N:215866`
`status`	Exact status, case-insensitive. Repeatable. See each dataset below.	`ongoing`
`date_from`, `date_to`	`document_date` range, inclusive.	`2026-01-01`
`sort`, `direction`	`document_date` (default) or `event_date`; `desc` (default) or `asc`. Missing dates sort last.	`sort=event_date`
`include_total`	Exact match count.	`true`
`limit`, `offset`	Page size (1–100, default 25) and offset.	`limit=50`

Drug applications

document_date is the first approval and event_date the most recent FDA action. status is approved once the original application was approved, otherwise FDA’s latest action code. details names the products, the application type and the latest submission.

curl -G https://api.pav.bio/v1/fda/applications \
  -H "Authorization: Bearer $PAV_API_KEY" \
  --data-urlencode "company_id=218" \
  --data-urlencode "include_total=true" \
  --data-urlencode "limit=3"

import os
import requests

resp = requests.get(
    "https://api.pav.bio/v1/fda/applications",
    headers={"Authorization": f"Bearer {os.environ['PAV_API_KEY']}"},
    params={"company_id": 218, "include_total": "true", "limit": 3},
)
resp.raise_for_status()
body = resp.json()
print("total:", body["pagination"]["total"])
for r in body["data"]:
    print(r["application_key"], "|", r["title"], "|", r.get("document_date"), "|", r["status"])

const params = new URLSearchParams({ company_id: "218", include_total: "true", limit: "3" });
const resp = await fetch(`https://api.pav.bio/v1/fda/applications?${params}`, {
  headers: { Authorization: `Bearer ${process.env.PAV_API_KEY}` },
});
const body = await resp.json();
console.log("total:", body.pagination.total);
for (const r of body.data) console.log(r.application_key, "|", r.title, "|", r.document_date, "|", r.status);

Example response (trimmed)

{
  "data": [
    {
      "record_key": "drug_application:BLA:761408",
      "record_type": "drug_application",
      "fda_organization_name": "ELI LILLY AND CO",
      "company": { "company_id": 218, "short_name": "eli_lilly", "name": "Eli Lilly" },
      "application_key": "BLA:761408",
      "title": "ONSWIK",
      "document_date": "2026-09-23",
      "event_date": "2026-09-23",
      "event_date_type": "latest_action",
      "status": "approved",
      "source_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761408",
      "details": {
        "application_type": "BLA",
        "products": "ONSWIK",
        "submission_count": 1,
        "latest_submission": { "submission_type": "ORIG", "submission_number": "1", "status": "AP", "status_date": "2026-09-23" }
      }
    }
  ],
  "pagination": { "limit": 3, "offset": 0, "total": 152 }
}

An application dossier

GET /v1/fda/applications/{application_key} returns the application, the other FDA records on it (Orange Book products, patents and exclusivities, Purple Book products, complete response letters, accelerated approvals), and up to 200 submissions with FDA’s action on each, newest first. records holds up to 500 rows; for an application with more, page its records with GET /v1/fda?application_key=.

curl https://api.pav.bio/v1/fda/applications/N:215866 \
  -H "Authorization: Bearer $PAV_API_KEY"

import collections
import os

import requests

resp = requests.get(
    "https://api.pav.bio/v1/fda/applications/N:215866",
    headers={"Authorization": f"Bearer {os.environ['PAV_API_KEY']}"},
)
resp.raise_for_status()
dossier = resp.json()
app = dossier["application"]
print(app["application_key"], "|", app["title"], "| first approved", app["document_date"])
print(dict(collections.Counter(r["record_type"] for r in dossier["records"])))
for s in dossier["submissions"][:3]:
    print(s["status_date"], s["submission_type"], s["submission_number"], s["status"], s.get("submission_class"))

const resp = await fetch("https://api.pav.bio/v1/fda/applications/N:215866", {
  headers: { Authorization: `Bearer ${process.env.PAV_API_KEY}` },
});
const dossier = await resp.json();
const app = dossier.application;
console.log(app.application_key, "|", app.title, "| first approved", app.document_date);
for (const s of dossier.submissions.slice(0, 3)) {
  console.log(s.status_date, s.submission_type, s.submission_number, s.status, s.submission_class);
}

Example response (trimmed)

{
  "application": {
    "record_key": "drug_application:N:215866",
    "record_type": "drug_application",
    "company": { "company_id": 218, "short_name": "eli_lilly", "name": "Eli Lilly" },
    "application_key": "N:215866",
    "title": "MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN",
    "document_date": "2022-05-13",
    "event_date": "2026-08-27",
    "event_date_type": "latest_action",
    "status": "approved",
    "details": { "application_type": "NDA", "submission_count": 14 }
  },
  "records": [
    { "record_key": "orange_book_product:N:215866:019", "record_type": "orange_book_product", "title": "MOUNJARO KWIKPEN", "event_date": "2026-01-20", "status": "RX" }
  ],
  "submissions": [
    { "submission_type": "SUPPL", "submission_number": "45", "status": "AP", "status_date": "2026-08-27", "submission_class": "Efficacy", "review_priority": "STANDARD" },
    { "submission_type": "SUPPL", "submission_number": "44", "status": "AP", "status_date": "2026-08-27", "submission_class": "Efficacy", "review_priority": "STANDARD" }
  ]
}

Complete response letters

One record per letter. document_date is the letter date, source_url the letter PDF, and status is Approved when the application was later approved and Unapproved otherwise.

curl -G https://api.pav.bio/v1/fda/complete-response-letters \
  -H "Authorization: Bearer $PAV_API_KEY" \
  --data-urlencode "include_total=true" \
  --data-urlencode "limit=2"

Example response (trimmed)

{
  "data": [
    {
      "record_key": "complete_response_letter:CRL_NDA218705_20260807.pdf",
      "record_type": "complete_response_letter",
      "fda_organization_name": "ITM Solucin GmbH",
      "company": { "company_id": 2877, "short_name": "itm_solucin", "name": "ITM Solucin GmbH" },
      "application_key": "N:218705",
      "title": "ITM Solucin GmbH — Complete response letter",
      "description": "COMPLETE RESPONSE",
      "document_date": "2026-08-07",
      "status": "Unapproved",
      "source_url": "https://download.open.fda.gov/crl/CRL_NDA218705_20260807.pdf"
    }
  ],
  "pagination": { "limit": 2, "offset": 0, "total": 365 }
}

Accelerated approvals

One record per product and approved indication (description), with the accelerated approval date (document_date) and its confirmatory requirements in details. status is ongoing (confirmatory trial pending; event_date is its projected completion), verified (converted to traditional approval) or withdrawn.

curl -G https://api.pav.bio/v1/fda/accelerated-approvals \
  -H "Authorization: Bearer $PAV_API_KEY" \
  --data-urlencode "status=ongoing" \
  --data-urlencode "include_total=true" \
  --data-urlencode "limit=2"

Example response (trimmed)

{
  "data": [
    {
      "record_type": "accelerated_approval",
      "fda_organization_name": "BAYER HEALTHCARE",
      "company": { "company_id": 267, "short_name": "bayer", "name": "Bayer" },
      "application_key": "N:219972",
      "title": "Hyrnuo (sevabertinib)",
      "description": "Treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test",
      "document_date": "2026-09-09",
      "event_date": "2029-10-31",
      "event_date_type": "projected_completion",
      "status": "ongoing",
      "details": {
        "category": "cancer",
        "confirmatory_requirements": [
          { "requirement": "4933-1: Complete the ongoing multicenter, randomized clinical trial, Study SOHO-02, ...", "projected_completion": "2029-10-31" }
        ]
      }
    }
  ],
  "pagination": { "limit": 2, "offset": 0, "total": 107 }
}

Advisory committee meetings

Meetings from FDA’s calendar, past and scheduled: the meeting title (committee and topic), the convening center, the meeting day (document_date), start and end times, and links to the briefing documents, minutes and other materials FDA posted. status is held or scheduled. Meetings name no company; search the committee or topic with q.

curl -G https://api.pav.bio/v1/fda/advisory-committee-meetings \
  -H "Authorization: Bearer $PAV_API_KEY" \
  --data-urlencode "q=oncologic" \
  --data-urlencode "include_total=true" \
  --data-urlencode "limit=2"

Example response (trimmed)

{
  "data": [
    {
      "record_type": "advisory_committee_meeting",
      "title": "April 30, 2026: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement - 04/30/2026",
      "description": "Center for Drug Evaluation and Research",
      "document_date": "2026-04-30",
      "event_date_type": "meeting",
      "status": "held",
      "source_url": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/april-30-2026-meeting-oncologic-drugs-advisory-committee-meeting-announcement-04302026",
      "details": {
        "center": "Center for Drug Evaluation and Research",
        "meeting_start": "2026-04-30T12:00:00Z",
        "meeting_end": "2026-04-30T21:00:00Z",
        "documents": []
      }
    }
  ],
  "pagination": { "limit": 2, "offset": 0, "total": 59 }
}

FDA records: every FDA record type in one endpoint.
Patents: drugs[].application_key joins a patent family to its application.
Companies

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Datasets

Working with the API

Integrations

Guides

FDA applications and reviews

Overview

Coverage

Endpoints

Filters

Drug applications

An application dossier

Complete response letters

Accelerated approvals

Advisory committee meetings

​Overview

​Coverage

​Endpoints

​Filters

​Drug applications

​An application dossier

​Complete response letters

​Accelerated approvals

​Advisory committee meetings

​Related

Overview

Coverage

Endpoints

Filters

Drug applications

An application dossier

Complete response letters

Accelerated approvals

Advisory committee meetings

Related