Changing Of The Guard At US FDA Continues With Unger Retirement
One of the US FDA’s most prominent review managers is retiring after nearly 25 years with the agency. Ellis Unger’s departure underscores a sense of transition in the leadership and mindset of the drug center.
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Unger Unplugged: FDA Needs Accelerated Approval To ‘Take More Chances’ – But Also A Clear Path To Withdrawal
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%.
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HHS Inspector General’s timeline means Congress won’t have findings to use during upcoming user fee renewal debate; ‘review’ is not an ‘investigation’ which could come with potentially more damning legal consequences for the agency.