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Pharmaceuticals / Regulatory Affairs

Industry Groups Endorse BsUFA II Proposals

Oct. 26, 2016

Industry groups endorsed the FDA’s commitment goals for BsUFA II, saying these proposals would improve review efficiency and ensure adequate staffing, and should be approved by Congress.

The BsUFA II goals will strengthen the agency’s review program and meet industry goals of providing timely reviews, David Gaugh, the senior vice president of sciences and regulatory affairs at the Generic Pharmaceutical Association’s Biosimilar Council, said, adding that the council “expresses its enthusiastic support” for the reauthorization.

Gaugh and other industry officials spoke at a meeting held to gather input on the program that will finance reviews of biosimilar applications from fiscal 2018 through fiscal 2022. The final version that the FDA is drafting will be forwarded to Congress.

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