---
title: "Search FDA Drug Approval Package Reviews"
method: GET
path: "/v1/sources/fda-drug-reviews/search"
tags: ["FDA Drug Approval Package Reviews"]
---

# Search FDA Drug Approval Package Reviews

`GET /v1/sources/fda-drug-reviews/search`

## Request

- Base URL: `https://api.assyro.com`
- URL: `https://api.assyro.com/v1/sources/fda-drug-reviews/search`
- Auth: none declared

Search the review documents in FDA's drug approval packages (Drugs@FDA, CDER's NDAs and BLAs): summary reviews, medical (clinical), statistical, clinical pharmacology, chemistry, pharmacology/toxicology, microbiology, cross-discipline and multidisciplinary reviews, with the action letters, labeling and correspondence of the same package, in full text where the PDF has a text layer. Use it for how FDA judged the studies behind an approved drug: the pivotal trials' design, endpoints, analyses, dose selection, and what reviewers accepted or criticized. Find by application number, product (brand or generic name), sponsor, discipline, approval date or words in the text. Each result gives the application, submission, product, sponsor, discipline and approval date. CBER's biologics are in search_cber_approvals. Only packages FDA posted online and Assyro has collected are held (most approvals from the late 1990s on); each search says what is not held, and finding nothing does not show FDA posted no review. Call read_fda_drug_review for the text.

## Query parameters

- `query` string: Words in the review's text, e.g. "non-inferiority margin" or "dose selection exposure-response".
- `applicationNumber` string: An NDA, ANDA or BLA number, e.g. "NDA 214952", "BLA125472" or "21-321".
- `product` string: Brand or generic name, e.g. "ACTEMRA" or "tocilizumab".
- `sponsor` string: The applicant, e.g. "Genentech".
- `discipline` 'summary review' | 'medical review' | 'statistical review' | 'clinical pharmacology review' | 'chemistry review' | 'pharmacology toxicology review' | 'microbiology review' | 'cross-discipline team leader review' | 'multidisciplinary review' | 'integrated review' | 'office director memo' | 'other review' | 'risk management review' | 'rems' | 'proprietary name review' | 'action letter' | 'labeling' | 'administrative documents and correspondence' | 'officer/employee list' | 'approval package' | 'other': Only one review discipline or package part, e.g. "statistical review" or "medical review".
- `dateFrom` string: Approved on or after this date (the submission's approval date), YYYY-MM-DD.
- `dateTo` string: Approved on or before this date, YYYY-MM-DD.
- `limit` integer: Documents to return, default 8.
- `offset` integer: Skip this many results (for paging), default 0.

## Response `200`

Matching records.

- SearchResponse
  - `version` unknown, required
  - `source` SourceRef, required
    - `id` string, required
    - `label` string, required
    - `authority` string, required
  - `total` integer, nullable, required: Total matches the source reports, when it says.
  - `records` Record[], required
    - `id` string, required: The source's own identifier for the record.
    - `title` string, required
    - `url` string, required: The record's page at the source, to verify it.
    - `authority` string, required: Who published the record.
    - `snippet` string, nullable, required: The part of the record that matched; null where the licence allows only a link.
    - `publishedDate` string, nullable, required
    - `version` string, nullable, required: The edition or revision read.
    - `fields` object, nullable, required: The source's own fields; null where the licence allows only a link.
    - `asOf` string, nullable, required: The day Assyro's copy of the source was read (YYYY-MM-DD).
    - `attribution` string: The attribution the source's licence requires, on sources that require one.
  - `note` string
  - `summary` string[]

## Other responses

- `400`: The request is not valid: an unknown parameter or an argument the source refuses.
- `404`: No such source or record.
- `429`: Rate limited; retry after the Retry-After header.
- `503`: The source cannot answer from Assyro's copy right now.

---

[API](https://skmtc.dev/assyro/apis/assyro-public-data-api.md) - [All operations](https://skmtc.dev/assyro/apis/assyro-public-data-api/llms.txt) - [OpenAPI document](https://skmtc.dev/assyro/apis/assyro-public-data-api/revisions/c861290c9f47?raw)