Never get surprised by an FDA action again.
One daily email on FDA inspections, warning letters, recalls, guidance, CFR changes, approvals and trials, filtered to the companies and topics you name.
Weekly digest free. Watchlists from $79/mo. No card required.
For biotech QA/RA, and for the CDMOs, CROs and consultants who want to know who just got inspected, funded or approved.
How it works
Three minutes to set up. Then it runs without you.
Build your watchlist.
Companies (your CDMO, your CRO, your competitors, or the biotechs you sell to), indications, product types, CFR parts, GxP areas. Rules match any of them.
We poll the public sources.
One name catches every agency’s record: the name FDA uses, the sponsor name ClinicalTrials.gov uses, the SEC filer. Each CFR change is mapped to its GxP area and the guidances that cite it. A broken source alerts us, never you.
Read one email.
Critical, Important, FYI. Each item: the fact, why it matters, which of your rules matched, and the source link.
Sources
Eight public sources, one taxonomy.
FDA warning letters
Every letter as it is posted, with the CFR sections cited
FDA inspection classifications
NAI, VAI and OAI outcomes and the citations behind them, by site
openFDA enforcement
Recalls by class, firm, and product type
Federal Register
Proposed and final rules, guidance availability, advisory committee notices
eCFR Title 21
Section-level amendments mapped to a GxP area and the guidances that cite them
ClinicalTrials.gov
New, terminated, suspended, and results-posted trials by indication and sponsor
Drugs@FDA and CRLs
Approvals and complete response letters as FDA publishes them
SEC EDGAR
8-K disclosures, Form D raises and public offerings, tied to the company
Pricing
Free weekly digest for everyone. A watchlist of your own from $79 a month.
Free
No card required
- Weekly industry top-5 digest
- Dashboard, last 7 days
- Every live FDA, SEC and ClinicalTrials.gov source
- Company explorer and profiles: pipeline, financials, FDA record
Pro
Billed monthly, cancel anytime
- Your watchlist: companies, indications, CFR parts, GxP areas
- Daily digest at your hour
- Instant email alerts on critical events
- Full archive, charts, saved views
- Ask AI: answers from your feed, events cited
- CFR change → GxP area → citing guidance