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PDUFA Clears Senate With Few Changes, House to Vote Next Week
The Senate overwhelmingly approved the omnibus FDA user fee bill 96–1 Thursday, rejecting a series of controversial amendments offered for vote on the floor. Senate leadership agreed to attach eight less-controversial drug-related amendments to the FDA Safety and Innovation Act, S. 3187, before it came to the floor. All eight amendments — including provisions to protect FDA whistleblowers and require an independent review of the agency’s drug review process — were adopted as part of the bill.
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