---
title: "Adverse FDA regulatory actions disclosed in 8-Ks: Complete Response Letters,"
method: GET
path: "/v1/biotech/fda-response-events"
---

# Adverse FDA regulatory actions disclosed in 8-Ks: Complete Response Letters,

`GET /v1/biotech/fda-response-events`

## Request

- Base URL: `https://api.alphanume.com`
- URL: `https://api.alphanume.com/v1/biotech/fda-response-events`
- Auth: one of:
  - API key in header `X-API-Key`
  - HTTP bearer

Adverse FDA regulatory actions disclosed in 8-Ks: Complete Response Letters,
full and partial clinical holds, and refuse-to-file letters, 2024+, each graded by
an explicit severity precedence rule with the evidence flags the grade depends on
served alongside it (new-trial-required, manufacturing-related, resubmission-path,
hold-lifted). Follow-ups and resolutions are linked per (issuer, drug program), so
an original hold row answers 'was it ever lifted, and how long did it take'.

By default only classified FDA events are returned (~196 rows); the ~1,520 audited
not-an-event rows the full-text sweep also retrieved are available with
include_rejects=true. The date window filters disclosed_date (the EDGAR filing
date); event_letter_date is extracted with its own precision enum and
days_letter_to_disclosure is the selective-disclosure measure -- on
initial_disclosure rows only (on follow-ups it measures distance to the original
letter). Selective disclosure is the headline caveat: a CRL disclosed only in a
10-Q, or never, is not here.

Requires an Alphanume Pro API key. A 403 PRO_SUBSCRIPTION_REQUIRED or
DATE_RANGE_RESTRICTED error means the key's plan does not cover the request --
it does not mean the data is missing.

## Query parameters

- `ticker` string
- `cik` string
- `event_type` string
- `filing_role` string
- `severity` string
- `resolved` string
- `include_rejects` string
- `drug_search` string
- `asset_key` string
- `date` string
- `date_gte` string
- `date_lte` string
- `date_gt` string
- `date_lt` string
- `updated_since` string
- `cursor_date` string
- `cursor_accession` string

## Response `200`

Matching rows.

- PaginatedEnvelope
  - `count` integer, required
  - `data` object[], required
  - `has_more` boolean, required
  - `next_cursor` object, nullable, required: Keyset cursor: pass its fields back as the cursor_* query parameters to fetch the next page.

## Other responses

- `400`: Invalid or conflicting query parameters.
- `401`: Missing or unrecognized API key.
- `403`: PRO_SUBSCRIPTION_REQUIRED: the key's plan does not include API access; every endpoint requires an active Pro subscription. DATE_RANGE_RESTRICTED: a legacy free-tier key asked for dates outside its window. In both cases the data is not missing.
- `429`: Rate limit exceeded (600/min); the body carries retry_after_seconds.

---

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