What's New on the FDA Drugs Site

May 5, 2011

Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
Drug Shortages: Current Drug Shortages: Digoxin Injection (updated)
Special Feature: FDA Encourages Pediatric Information on Drug Labeling
Guidance for Industry: Submission of Summary Bioequivalence Data for ANDAs (PDF - 138 KB)
Postmarket Requirements and Commitments
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Prescription Drug User Fee Act (PDUFA) Meetings:
FDA-Industry Meeting Minutes, February 24, 2011
FDA-Industry Meeting Minutes, February 10, 2011
FDA-Industry Meeting Minutes, February 4, 2011