content and format of chemistry

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Content and Format of Chemistry, Manufacturing, and Controls (CMC) in a New Drug Application (NDA) -PET Drug ProductsRavindra K Kasliwal, Ph.D. Office of New Drug Quality Assessment Center for Drug Evaluation and Research U.S. Food and Drug Administration 14-Apr-2010 1 Outline Overview of NDA Content and Format General Requirement for Providing CMC Information. Resources for NDA Resources for CMC CMC Section...
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content and format of chemistry
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