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FDA’s Pepaxto Decider: Peter Marks To Handle Oncopeptides’ Appeal Of Accelerated Approval Withdrawal

 
• By Sue Sutter

CBER director will decide whether the multiple myeloma drug should be withdrawn under new expedited withdrawal procedures; it's the third time FDA leaders have asked senior officials in the biologics center to help decide the fate of a CDER-regulated accelerated approval drug.

peter marks the decider
CBER Director Peter Marks has been delegated the authority to decide if Pepaxto should remain on the market. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock, FDA images

The US FDA once again has turned to Center for Biologics Evaluation and Research leaders to oversee the proposed withdrawal of an accelerated approval product regulated by the drugs center.

Commissioner Robert Califf has tapped CBER Director Peter Marks to serve as his designee in a dispute over the Center for Drug Evaluation and Research’s proposed withdrawal of Oncopeptides...

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