Generics Industry Loses 'Champion' As Gottlieb Steps Down
Reacting to Scott Gottlieb’s decision to step down as head of the FDA, local industry association the AAM has bemoaned the loss of a “champion of patient access”.
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The US Food and Drug Administration has begun searching for a new director for its Office of Generic Drugs, after announcing that Sally Choe will leave the agency in early October.
Proposals as part of the latest US budget to amend provisions around the 180-day exclusivity incentive for generics could risk weakening the critical driver of competition, the AAM has warned.
Draft guidance on the approval pathway for competitive generic therapies (CGTs) has been published by the FDA in the agency’s latest move to advance generic drug competition.