Industry Perspective on FDA’s Draft Guidance on CGMPs for Combination Products

Описание к видео Industry Perspective on FDA’s Draft Guidance on CGMPs for Combination Products

James A. Boiani, MS, JD, of Epstein Becker & Green presents an industry perspective on FDA’s draft guidance on current Good Manufacturing Practice (CGMP) for combination products. Boiani’s presentation was part of the workshop, CGMPs for Combination Products—Understanding and Applying FDA’s Draft Guidance: An Interactive Analysis with FDA and Industry, presented by the Regulatory Affairs Professionals Society (RAPS) and the Combination Products Coalition (CPC).

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