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Lawmakers Strike Deal To Reauthorize FDA User Fee Agreements

The agreement extends the agency's authority to collect fees from drug and medical device manufacturers. Without the fees, 5,000 Food and Drug Administration employees could be laid off and drug reviews would be prolonged.

Modern Healthcare: Lawmakers Reach Bipartisan Deal To Extend FDA User Fees 
Legislators reached a tentative deal Friday to reauthorize the FDA's authority to collect user fees, extending funding to maintain and streamline the agency's product approval process. The bipartisan leaders of the Senate's and U.S. House of Representatives' health committees released a draft of the bipartisan Food and Drug Administration Reauthorization Act Friday. The act would reauthorize the FDA's four user fee agreements that renew the FDA's authority to collect user fees from the makers of prescription brand drugs, medical devices, generic drugs and biosimilars, and several crucial programs at the FDA. The fees would incrementally increase year over year. (Kacik, 4/14)

Morning Consult: Senior Republicans, Democrats Reach Deal On FDA User Fee Reauthorization
Top Republicans and Democrats in Congress have reached a preliminary deal to extend funding for several programs that are crucial to the approval of new drugs and medical devices in the United States. The deal announced Friday would reauthorize four user fee agreements that drug and medical device makers and the Food and Drug Administration depend upon to get products approved. (Reid, 4/14)

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