Tag Archive | "clinical trials"

Woodcock Holds Court: Notes from a Lively CDER Town Hall


A town hall meeting held last week at DIA 2010 in Washington, D.C. featured seven of CDER’s key personnel, but it was clear from the start of the meeting who the star of the show would be. Grande Starbucks cup in hand, CDER director Janet Woodcock kicked off the session by providing an overview of hot topics currently on CDER’s plate, and presided over an ensuing Q&A session in which she spoke with candor, passion, and humor about issues critical to CDER’s work. Woodcock’s colleagues played off her lead and, for those used to droll or technical dialogue from the Agency, this session was a breath of fresh air.

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Byrn: QbD Can Double the Number of Clinical Trials


By Paul Thomas, Senior Editor

The news on new drug approvals is dire, and critical of FDA. BusinessWeek notes that, as we all know, increased R&D spending has not led to an increase in the number of new drugs gaining approval. In fact, quite the opposite.

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