Office of Surveillance and Epidemiology (OSE) Home

•  REMS@FDA (Approved Risk Evaluation and Mitigation Strategies (REMS)

• Drug Safety and Risk Management (DSaRM) Advisory Committee gained full committee status on June 1, 2002.
  • Meeting, member, and charter information for the DSaRM  Advisory Committee.  
• MedWatch  MedWatch, the FDA Safety Information and Adverse Event Reporting Program, provides safety information for all FDA-regulated medical products (drugs, biologics, medical devices, and dietary supplements) to both healthcare professionals and the general public. 
  • MedWatch Partners work with FDA to help keep their members informed about medical product safety information

• Sentinel System:  In 2008, FDA launched the Sentinel Initiative to establish a national electronic system to monitor regulated medical products.  Sentinel includes the Active Postmarket Risk Identification and Analysis (ARIA) system mandated by the 2007 FDA Amendments Act and enables active drug safety surveillance.
• Division of Epidemiology and Drug Utilization Analysis Staff