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Draft Guidance for Industry: Information Requests and Discipline Review Letters Under Draft Guidance for Industry: Information Requests and Discipline Review Letters Under

Draft Guidance for Industry: Information Requests and Discipline Review Letters Under - PowerPoint Presentation

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Uploaded On 2019-02-11

Draft Guidance for Industry: Information Requests and Discipline Review Letters Under - PPT Presentation

Overview of Presentation Background Discipline Review Letter DRL Information Request IR IRDRL Timing IRDRL Responses Key Takeaways Resources wwwfdagov Background The Generic Drug User Fee Amendments of 2017 GDUFA II was signed into law on August 18 2017 in order to facilitate ID: 751448

discipline review gdufa drl review discipline drl gdufa fda enhancements information program drls irs request anda letter goals fiscal

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