Unger Unplugged: FDA Needs Accelerated Approval To ‘Take More Chances’ – But Also A Clear Path To Withdrawal

 
• By Kate Rawson

Former cardiology review office director Ellis Unger suggests 70% chance for AA drugs to confirm benefit is an appropriate benchmark, but agency comes nowhere close to withdrawing the remaining 30%.

Accelerated Approval was “a stroke of genius,” when it was created 30 years ago, but the Food & Drug Administration still needs an easier path to removing a product from the market when confirmatory trials fail to show benefit, former FDA review manager Ellis Unger said during a recent Everylife Foundation Congressional caucus briefing.

Unger’s participation during Rare Disease Week marked his first public appearance to discuss FDA regulatory policy since leaving the agency...

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