FDA Drug Approval & Recall Watch — Daily Pharma Monitor

Daily delta monitor of FDA drug approvals (Drugs@FDA) and drug recalls (openFDA enforcement) — for Pharma Regulatory Affairs, Pharmacovigilance, and US Market Access teams.

Webhook-ready alerts in seconds. Unified output schema with our EU regulator monitors so you can join FDA + EMA + MHRA in one query.

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What this Actor does

On each scheduled run:

1. Queries openFDA /drug/drugsfda.json for the last 90 days of NDA/ANDA/BLA submissions with status AP (approved).
2. Queries openFDA /drug/enforcement.json for the last 90 days of drug recalls (Class I/II/III).
3. Computes a stable identity per record (NDA + submission + status, OR recall number + status) and diffs against the seen-set in its KV store.
4. Pushes only new or changed records to the dataset — never duplicates.
5. Optionally fires a HMAC-signed webhook for every new alert.
6. Charges once per calendar month (subscription) plus per-alert.

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Use Cases

1. Pharma Pharmacovigilance — react to Class I recalls within minutes

A PV team subscribes with recallClassFilter: ["Class I"] and a Slack webhook. The moment FDA publishes a Class I recall on a competitor's product (or worse, their own), Slack pings the on-call PV lead with the openFDA URL pre-resolved. From regulator publication to internal alert: under 60 seconds vs. ~24h via daily email digests.

2. US Market Access — track every NDA/BLA approval in indication

A US market-access analyst monitors first-in-class and follow-on approvals: sources: ["approvals"]. Each new approval flows into their internal pipeline tracker with sponsor + dosage form + approval-class-code. Saves 6-10 hours/week of manual Drugs@FDA portal-trawling.

3. Regulatory CI — monitor competitor sNDAs / supplemental approvals

A regulatory CI specialist filters on a known competitor's NDA list (post-process) to detect supplemental applications (sNDA) — labelling changes, new indications, new pediatric studies. Identifies competitor lifecycle moves 2-4 weeks before press release.

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Output

Every dataset item conforms to the unified RegulatorAlert schema shared across this publisher's Tier-A monitoring actors. Drop into your warehouse alongside EMA / MHRA / Swissmedic outputs — same column layout, same field semantics.

Example item — Class I recall

{
  "scrapedAt": "2026-05-07T07:00:00.000Z",
  "sourceUrl": "https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1234-2026",
  "sourceDomain": "accessdata.fda.gov",
  "actorVersion": "1.0.0",
  "dataHash": "8a2f...d0",

  "regulator": "FDA",
  "alertType": "recall",
  "recordId": "D-1234-2026",
  "changeKind": "new",

  "productName": "AcmePharm Insulin 100 IU/mL",
  "activeSubstance": "insulin lispro",
  "inn": "insulin lispro",
  "atcCode": null,
  "manufacturer": "AcmePharm Inc.",
  "therapeuticArea": null,
  "indication": null,

  "publishedAt": "2026-05-06",
  "effectiveAt": "2026-05-04",
  "severity": "critical",
  "summary": "Class I: AcmePharm Insulin 100 IU/mL recall. Reason: mislabeling — vials labelled as 100 IU/mL contain 50 IU/mL.",
  "rawSnippet": "AcmePharm Insulin 100 IU/mL, 10 mL vials, lots 12345...",

  "documents": [{ "kind": "FDA-recall", "url": "https://...", "title": "D-1234-2026" }],
  "extras": {
    "recallNumber": "D-1234-2026",
    "classification": "Class I",
    "status": "Ongoing",
    "voluntary": "Voluntary",
    "distribution": "Nationwide"
  }
}

Webhook payload

If you set webhookUrl:

{
  "eventId": "8a2f...d0",
  "eventType": "fda.recall",
  "actor": "fda-drug-approval-watch",
  "emittedAt": "2026-05-07T07:00:01.123Z",
  "schemaVersion": 1,
  "data": { /* the alert object above */ }
}

X-Azureblue-Signature: sha256=<hex> header included if webhookSecret is set.

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Pricing

Event	Charge	When it fires
Monthly subscription	$79	Once per calendar month per user, on first delta-mode run
Per alert	$0.02	Per new/changed approval or recall pushed to the dataset

Typical pharma PV buyer: ~10-30 alerts/month → $79 + ~$0.40/mo ≈ $80/mo all-in. Compare to a single missed Class I recall costing $1M+ in remediation.

Trial mode (mode: "trial") returns 5 results, no charges, no state writes.

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Compliance

• Public-data only — sourced from openFDA (https://api.fda.gov), the FDA's official open-data interface. No login, no scraping of paywalled endpoints.
• No PHI — Drugs@FDA + recall enforcement are product-level metadata, not patient records.
• GDPR Art. 6(1)(f) / US public-records law — buyer is responsible for downstream use of the data.
• Audit log — every fetch recorded in the actor's KV store (URL + timestamp, PII-redacted).

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Sister Actors — same publisher, complementary coverage

• ema-drug-approval-watch — same alert schema, EMA EPAR side
• bfarm-pei-pharmacovigilance-monitor — German PV (Rote-Hand-Briefe, BfArM, PEI)
• medical-device-recall-scraper — FDA medical-device recalls (separate from drug recalls)
• drug-interaction-checker — RxNorm-based pairwise drug interaction lookup
• pubmed-abstract-scraper — PubMed metadata for the products in your alert stream

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Changelog

See CHANGELOG.md.