# Changelog of FDA Drug Approval & Recall Watch — Pharma Monitor (`azureblue/fda-drug-approval-watch`) Actor

- **URL**: https://apify.com/azureblue/fda-drug-approval-watch/changelog.md
- **Full Actor documentation**: https://apify.com/azureblue/fda-drug-approval-watch.md

## Changelog — FDA Drug Approval & Recall Watch

### \[1.0.0] — 2026-05-07

Initial public release.

#### Added

- Daily delta monitoring of openFDA `/drug/drugsfda.json` (approvals) + `/drug/enforcement.json` (recalls)
- Three modes: `delta` (recurring), `snapshot` (full 90-day rebuild), `trial` (free, 5-result preview)
- Stable record-key per approval (NDA + submission-type + submission-number + status) and per recall (recall-number + status) — supplemental approvals fire as deltas
- Self-healing baseline: 30-day baseline reset prevents corrupt state from missed schedule cycles
- Optional HMAC-signed webhook delivery with retry + dead-letter queue
- Recall-class filter (Class I / II / III) — defaults to all
- Source filter (approvals only, recalls only, or both)
- PAY\_PER\_EVENT pricing: $79 monthly subscription + $0.02 per pushed alert
- Audit log written to KV store (url + timestamp, PII-redacted) for compliance traceability
- Unified `RegulatorAlert` output shape — identical schema across all azureblue Tier-A monitoring actors

#### Known limitations

- FDA Warning Letters are HTML-only on fda.gov; not included in v1. Planned for v1.1 once the HTML scraper is stable.
- `therapeuticArea` and `atcCode` are null for FDA records — openFDA does not expose these fields.