Pricing

Pay per event

FDA Drug Approval & Recall Watch — Pharma Monitor

Daily delta monitor of FDA drug approvals (Drugs@FDA) and drug recalls (openFDA enforcement) — for Pharma Regulatory, Pharmacovigilance, and US market access teams. Webhook-ready alerts.

Pricing

Pay per event

Rating

0.0

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Developer

azureblue

Actor stats

Bookmarked

Total users

Monthly active users

11 days ago

Last modified

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.

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Search the FDA's **Drugs@FDA database of 28,000+ drug applications** — including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs/generics), and Biologics License Applications (BLAs).

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OpenFDA Drug Adverse Events & Recall Scraper

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Scrape FDA drug adverse events, drug labels, and food enforcement recalls from the openFDA public API — no auth required.

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