Product Specific Guidances (PSGs) (3of16) Generic Drugs Forum 2020

Автор: U.S. Food and Drug Administration

Загружено: 2020-05-01

Просмотров: 1268

Описание: Dave Coppersmith and Myong-Jin Kim from CDER’s Office of Generic Drugs provide information on product-specific guidances (PSGs). These guidances identify the methodology for developing generic drugs and generating the evidence needed to support generic approval. They discuss the issuance of PSGs and upcoming PSGs for complex generic drug product development.
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Product Specific Guidances (PSGs) (3of16) Generic Drugs Forum 2020

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