Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

FDA Resources on Drugs and Devices


Drug and Device Information from the US Food and Drug Administration

CDER - Center for Drug Evaluation and Research
CDRH - Center for Devices and Radiological Health
CBER - Center for Biologics Evaluation and Research


Drug Action Packages

Drugs@FDA - drug products approved by CDER at FDA
New Drug Applications (Biologics) - drug products approved by CBER at FDA
Licensed Product Approvals - products approved by CBER at FDA


Device Approval Packages

PMA CDRH - device premarket approval applications
PMA CBER - biologic device premarket approval applications
510(k) CDRH - device premarket notifications
510(k) CBER - biologic device premarket notifications


Drug and Device Safety Information

Public Health Advisories MedWatch - FDA safety information and adverse event reporting program
Drug Safety Initiative - variety of information about drug safety issues
Medical Device Safety - device recalls, alerts, and other safety information
Device Public Health Notifications - risks associated with the use of medical devices
Biologics Safety Information - safety notifications by CBER


Other Relevant Information

Advisory Committee Materials - may discuss efficacy and safety of drugs and devices and summarize results of clinical trials
Section 505A Reviews - summaries of reviews of pediatric studies
Pediatric Labeling Changes - Pediatric Research Equity Act (PREA) and Pediatric Exclusivity labeling changes (CDER)
Section 505B Labeling Changes - Pediatric Research Equity Act (PREA) labeling changes (CBER)