Non-Complex Drug Products and Product-Specific Guidances

Автор: U.S. Food and Drug Administration

Загружено: 2021-05-14

Просмотров: 844

Описание: Myong-Jin Kim from CDER’s Office of Generic Drugs discusses non-complex drug products and GDUFA II commitments of non-complex new chemical entities (NCEs) and the format and content of product-specific guidances (PSGs) of non-complex drug products. She also shares a general framework of how PSGs of non-complex drug products are developed and revised and a recent example of significant PSG revisions.

Learn more at https://www.fda.gov/drugs/fda-product...
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Non-Complex Drug Products and Product-Specific Guidances

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