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News List

Advancing Generic Drug Development: Translating Science to Approval fda.gov
August 25, 2021
The purpose of the public workshop is to communicate how outcomes from FDA research conducted under the Generic Drug User Fee Amendments (GDUFA) guide and facilitate generic drug development, regulatory assessment, and approval.
FDA Posts FY2020 GDUFA Fees contractpharma
July 26, 2019
he fee for U.S. CMO FDF facilities will drop 7% next year.
An Overview of the User Fee Systems concerning the U.S. Pharmaceutical Product Review en-cphi.cn
November 06, 2017
The U.S. government promulgated the FDA Reauthorization Act of 2017 (FDARA) in August 2017.Let's learn about those user fee systems one by one.