Draft Guidance for Industry: Information Requests and Discipline Review Letters Under GDUFA PowerPoint Presentation, PPT - DocSlides

Download natalia-silvester | 2019-02-11 | General Overview of Presentation. Background. Discipline Review Letter (DRL). Information Request (IR). IR/DRL Timing . IR/DRL Responses. Key Takeaways. Resources. www.fda.gov. 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

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Draft Guidance for Industry: Information Requests and Discipline Review Letters Under GDUFA

Draft guidance for industry: information requests and discip

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