1. Pink Sheet

FDA “Progressive Approval” And “Exceptional Approval” Pathways Possible Under Senate Bill

 
• By Derrick Gingery

Legislation being drafted by Sen. Kay Hagan, D-N.C., would formalize FDA practices of approving drugs in certain circumstances where the evidence needed for a standard approval cannot be generated.

A bill awaiting introduction in the Senate would establish two new drug approval mechanisms for FDA.

Progressive and Exceptional approval, as they are named in the draft bill, would essentially codify existing FDA practices of allowing drugs in certain cases to reach the market without the...

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