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Pharmaceuticals / Regulatory Affairs

Industry Supports GDUFA II Proposals, Advancing Reauthorization of Fee Program

Oct. 28, 2016

Industry groups have backed the FDA’s commitment goals for GDUFA II, bringing the user fee program for generics makers closer to reauthorization after a public meeting.

Industry representatives from GPhA, the Bulk Pharmaceuticals Task Force and the Pharma and Biopharma Outsourcing Association say they fully endorse the provisions under GDUFA II, noting that the user fee program will provide expedited reviews, increased communication and greater transparency.

The FDA held its public meeting on GDUFA II as part of the reauthorization of the user fee program that will finance its generics program from FY 2018 to FY 2022.

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