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FDA Cancer Head Defends Path Used for Biogen Alzheimer Approval

July 29, 2021, 5:39 PM

The FDA’s cancer chief pushed back against criticisms over the agency’s expedited approval mechanisms, calling them one-sided arguments that fail to recognize the benefits of making potentially lifesaving treatments available more quickly.

“Do you think accelerated approval is under attack? I do,” Richard Pazdur, director of the Food and Drug Administration’s Oncology Center of Excellence, said Thursday at a Friends of Cancer Research online event.

Pazdur’s remarks follow the FDA’s controversial decision to grant accelerated approval to Biogen’s Alzheimer’s drug. It prompted the resignations of several scientists on the agency’s advisory panel, which said there was incomplete data on the ...

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