Entries from HEALTH LAW SECTION BLOG tagged with 'post approval study'

FDAAA of 2007 and "REMS"

From CDER's email news of today: FDA provides Q&A on the Federal Register Notice on Drugs and Biological Products Deemed to Have A Risk Evaluation and Mitigation Strategy ("REMS"). (1) [re: 3/27/08 Federal Register Notice see (2)] FDA is: identifying...

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