> ## Documentation Index
> Fetch the complete documentation index at: https://docs.pav.bio/llms.txt
> Use this file to discover all available pages before exploring further.

# FDA applications and reviews

> FDA drug applications with their submissions and records, complete response letters, accelerated approvals and advisory committee meetings.

## 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`](/datasets/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.

<CodeGroup>
  ```bash cURL theme={null}
  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"
  ```

  ```python Python theme={null}
  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"])
  ```

  ```javascript JavaScript theme={null}
  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);
  ```
</CodeGroup>

```json Example response (trimmed) theme={null}
{
  "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=`.

<CodeGroup>
  ```bash cURL theme={null}
  curl https://api.pav.bio/v1/fda/applications/N:215866 \
    -H "Authorization: Bearer $PAV_API_KEY"
  ```

  ```python Python theme={null}
  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"))
  ```

  ```javascript JavaScript theme={null}
  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);
  }
  ```
</CodeGroup>

```json Example response (trimmed) theme={null}
{
  "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.

```bash theme={null}
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"
```

```json Example response (trimmed) theme={null}
{
  "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`.

```bash theme={null}
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"
```

```json Example response (trimmed) theme={null}
{
  "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`.

```bash theme={null}
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"
```

```json Example response (trimmed) theme={null}
{
  "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 }
}
```

## Related

* [FDA records](/datasets/fda): every FDA record type in one endpoint.
* [Patents](/datasets/patents): `drugs[].application_key` joins a patent family to its application.
* [Companies](/datasets/companies)