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FDA User Fee Lapse Would ‘Devastate’ Public Health, Califf Says

Sept. 20, 2022, 8:27 PM

The head of the FDA says he’s optimistic Congress will reauthorize the agency’s user fees as time dwindles for lawmakers to reach an agreement.

“I’m getting a lot of reassurance that it will get through,” Food and Drug Administration Commissioner Robert M. Califf said Tuesday about negotiations on Capitol Hill to reauthorize the fees drug and device companies pay to have their products reviewed.

Senate health committee leaders are aiming to attach user fee reauthorization language to a continuing resolution that would keep the government funded past September.

Drug and device companies would see major delays in their products coming ...