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
CooperSurgical, Inc. — Class I: INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing c
NARA ORGANICS RECALLS ALL LOTS OF NARA INFANT FORMULA BECAUSE OF POSSIBLE HEALTH RISK
Surgical Stapler Reload Recall: Intuitive Surgical Removes 8mm SureForm 30 Gray Reloads
Early Alert: Thoracic Stent Graft Issue from Bolton Medical
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