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FDA publishes two final guidances for industry: Orange Book Questions and Answers; Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe

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...

How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors

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...