Califf, Industry Call For Legislation To Refine Accelerated Approval Path

By Beth Wang / January 11, 2022 at 6:27 PM
FDA Commissioner-nominee Robert Califf and drug and biologics industry representatives said Congress needs to write legislation to help speed collection of postmarket data on drugs approved under FDA’s Accelerated Approval pathway. Califf warned lack of speedy postmarket confirmatory evidence for those drugs creates myriad problems for CMS, which must decide whether to cover the drugs. Califf made the remarks over the weekend, just days before CMS decided to cover Biogen’s controversial and expensive Alzheimer’s drug Aduhelm (aducanumab) , which FDA...

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