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FDA mulls advisory committee overhaul

This article was originally published in The Gray Sheet

Executive Summary

"I think it is time to quietly put together a wholesale review" of the advisory committee program, Acting FDA Commissioner Lester Crawford tells Medical Device Manufacturers Association annual meeting June 10 in response to membership concerns about the utility of drug and device panels. "This isn't the first time I have thought about [looking at the process]," Crawford said, noting that the idea has assumed greater significance with recent panel overrules by FDA in all five regulated product areas. HHS leadership has expressed concern with the number of experts becoming ensconced on panels after serving multiple terms, he said...
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