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August 12, 2022
Ahead of this year’s reauthorization of the Generic Drug User Fee Amendments (GDUFA) , FDA has established a docket to solicit comments on the content of Appendix A in the July 2018 guidance for...
August 2, 2022
Today, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug...
July 25, 2022
July 2022 As part of FDA’s continued efforts to improve transparency and provide helpful information to regulated industry and the public, the agency is issuing two final guidances for generic drug...
February 12, 2021
How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors: Facing several regulatory challenges related to the review of abbreviated new drug applications (ANDAs), Congress first...