On June 26, 2012, the Senate gave final approval to S. 3187, the Food and Drug Administration Safety and Innovation Act, following House action on June 20, 2012. The sweeping, bipartisan legislation would reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee Act, and authorize user fee programs for generic drugs and biosimilar drugs. As part of the drug and device user fee reauthorization process, the FDA would commit to certain performance goals and to fostering more interaction and predictability between industry and FDA during the review process. In addition, the bill would, among other things: take a variety of steps to alleviate drug shortages and protect the drug supply chain (although it does not include a national track-and-trace program); permanently authorize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act; offer incentives for the development of new qualified infectious disease products; promote expedited review of “breakthrough therapy” drugs; and make a variety of FDA administrative reforms. The President is expected to sign the bill.
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Congress clears FDA Safety & Innovation Act
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