On 30 September 2009, the FDA issued a new draft guidance for industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications. The guidance describes the content and format of a REMS, which the FDA was authorized to require by provisions of the FDA Amendments Act (FDAAA) [...]
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You are currently browsing the Drug Kennel weblog archives for the day Thursday, October 29th, 2009.
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Intermezzo® Held Up at FDA
Published October 29th, 2009 in 505(b)(2) Issues and News Commentary. 0 CommentsTranscept Pharmaceuticals announced yesterday (10/28/09) that it had received a complete response letter from the FDA concerning its NDA for Intermezzo® (zolpidem tartrate sublingual tablet). We’ve been following this drug in this blog for a couple of years. Recall that this drug is for the treatment of insomnia when a person awakens in the middle [...]