FDA signal extraction — not news summaries.
simplyFDA continuously monitors openFDA and official FDA feeds, then uses AI to extract what each update actually means for Regulatory Affairs, Clinical Operations, QA, and Pharmacovigilance teams — with the original FDA source one click away.
Stop scanning openFDA, MedWatch, recalls, and press feeds manually. We do it hourly and surface only what matters.
Every update gets a structured AI brief — what happened, who is affected, why it matters, and what to do — separated from FDA facts.
Importance scoring, warning-letter pattern detection, and saved collections help your team respond before issues compound.
Highest-priority FDA signals
Latest FDA intelligence
FDA domains we monitor
Approvals, label changes, MedWatch alerts, drug enforcement reports.
510(k), PMAs, MDR adverse event reports, recalls and safety alerts.
BLAs, cell & gene therapy, vaccines, and CBER enforcement signals.
Pattern analysis of recurring findings, observations, and CAPA failures.
Plans for individuals and teams
- Unlimited updates
- Full archive
- Advanced filters
- Email alerts
- Weekly intelligence reports
- Everything in Pro
- Full learning platform
- Quizzes & assessments
- Downloadable resources
- Saved collections