1. Pink Sheet

Medical Advances Get More Chances When Safety Issues Arise

 
• By Bridget Silverman

Withdrawn “me too” NMEs were removed from the market sooner after post-marketing safety signals than first-in-class or advance-in-class NMEs, showing the importance of available alternative therapy (or the lack thereof) in post-marketing risk management decisions.

“Me too” drugs do not get much benefit of the doubt from FDA when safety concerns surface after approval, but the agency will go to great lengths to keep drugs considered to be medical advances available for at least some patients.

New molecular entities withdrawn from the market after safety issues emerged were equally split between “me too” drugs and medical...

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