FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sound­ing the alarm over its ac­cel­er­at­ed ap­proval path­way as back­lash con­tin­ues over the re­cent nod in fa­vor of Bio­gen’s Alzheimer’s drug Aduhelm, and an ODAC meet­ing on six such ap­provals that could po­ten­tial­ly be pulled from the mar­ket — two of which al­ready have.

“Do you think ac­cel­er­at­ed ap­proval is un­der at­tack? I do,” Rick Paz­dur, head of FDA’s On­col­o­gy Cen­ter of Ex­cel­lence, said at a Friends of Can­cer Re­search we­bi­nar on Thurs­day.

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