Senate Expands Infant Formula Safety, Supply Workload For FDA, Industry In User Fees Bill
HELP Committee passes five-year reauthorization of FDA drug, medical device and biosimilar user fees with separate provisions expanding agency’s authority to regulate infant formula manufacturing and marketing and establishing Office of Critical Foods in CFSAN.
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One voice emerged from the committee markup session as a potential cosmetics industry ally. In his opening remarks, ranking member Richard Burr, R-NC, said, “I worry that we’re rewarding bad behavior. Is this the time to expand FDA authority in any space, including diagnostic tests, cosmetics, and dietary supplements?”
Abbott's s Christopher Calamari, Gerber's Scott Fitz and Reckitt Robert Cleveland didn't have ng answers about immediately solving supply shortage or about preventing another one when they testified before Oversight and Investigation Subcommittee.