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GDUFA II Training - Performance Goals, Vince Sansone (U.S. Food and Drug Administration) View |
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GDUFA II Training IR and DR Letters, Michael Folkendt (U.S. Food and Drug Administration) View |
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GDUFA II – Review Timelines (14of27) Generic Drugs Forum 2018 (U.S. Food and Drug Administration) View |
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GDUFA II (9/28) Generic Drugs Forum 2017 (U.S. Food and Drug Administration) View |
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GDUFA (U.S. Food and Drug Administration) View |
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GDUFA II Training - Post Complete Response Letter Meeting Request, Anh Bui (U.S. Food and Drug Administration) View |
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Drug Master Files from a GDUFA II User Fee Perspective (U.S. Food and Drug Administration) View |
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What’s New in the Inactive Ingredient Database (IID) (U.S. Food and Drug Administration) View |
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Pre-ANDA Meeting or Controlled Correspondence (4of28) Generic Drugs Forum – Apr. 3-4, 2019 (U.S. Food and Drug Administration) View |
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Development of Single, Shared System REMS (10/28) Generic Drugs Forum 2017 (U.S. Food and Drug Administration) View |