1. Pink Sheet

Using REMS to Ram Drugs through FDA Faster

 
• By Cole Werble

FDA's use of Risk Evaluation & Mitigation Strategies will require NDA and BLA sponsors to provide more rigorous definitions of patient populations. Former FDA Commissioner Kessler thinks that may break the logjam on approvals.

Former FDA Commissioner David Kessler, MD, sees a way out of the new product drought for pharma in the just-passed Food & Drug Administration Amendments Act of 2007.

While many in industry remember Kessler as the commissioner who led a major assault on off-label use of drugs in the early 1990s, he prides himself on being an advocate...

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