BioWorld: MDMA’s Leahey says quality of reviews more important than speed in user fee programs

Apr 19, 2022, 00:00 AM
The U.S. FDA’s draft device user fee agreement was months late in arriving on Capitol Hill, a fact which also delayed the public meeting on the draft, an event that finally took place April 19. The meeting kicked off with an acknowledgement by second-time FDA commissioner Robert Califf of the growing role of user fees in FDA finances, but Mark Leahey, president and CEO of the Medical Device Manufacturers Association (MDMA), said that the quality of FDA reviews was at least as important as the timeliness of those reviews even though the user fee deals include many deadline-based metrics.

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