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US FDA Rethinking Post-Market Safety Function As Part Of New Drug Review 'Modernization'

 
• By Michael McCaughan

CDER Deputy Director Cavazzoni is leading the review, further indicating her status as heir-apparent to long-time drug center director Janet Woodcock. 

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How modern will OND look after the reorganization?

US FDA’s Center for Drug Evaluation & Research Deputy Director for Operations Patrizia Cavazzoni is overseeing a “ground up re-evaluation” of the agency’s approach to post-marketing drug safety as part of the broader reorganization of FDA’s new drug review program.

“We’re going to take a step back and look at how we regulate safety and safety reporting and analysis of safety in the post-marketing period. It will really be a sort of ground up re-evaluation of what we do,” CDER Director Janet Woodcock said at the Food & Drug Law Institute annual meeting May 3

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