FDA User Fee Reauthorization Clears Hurdle In Senate With Bipartisan Support image

Health Affairs Blog, May 15, 2017
Rachel Sachs (Academic Fellow Alumna)

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From the article:

On Thursday, May 11, the Senate Committee on Health, Education, Labor and Pensions marked up the proposed Food and Drug Administration (FDA) user fee reauthorization bill and voted 21-2 to advance it to the full Senate. The bill would reauthorize the fee system for the FDA’s approval of drugs, medical devices, generic drugs, and biosimilars. Recognizing both the must-pass nature of the bill and the partisan climate in Congress right now, the committee and its staff smartly managed to keep the bill fairly clean, adding few non-funding related provisions relative to some past user fee agreements (UFAs). Still, the full text clocks in at just under 200 pages, including amendments.

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