CGMPs for Combination Products: Understanding and Applying FDA’s Draft Guidance - Intro

Описание к видео CGMPs for Combination Products: Understanding and Applying FDA’s Draft Guidance - Intro

Introductory remarks from CGMPs for Combination Products—Understanding and Applying FDA’s Draft Guidance: An Interactive Analysis with FDA and Industry. FDA and industry presenters examined the agency’s draft guidance on current Good Manufacturing Practice (CGMP) for combination products, FDA panelists addressed questions, and breakout groups explored case studies. The workshop was presented by the Regulatory Affairs Professionals Society (RAPS) and the Combination Products Coalition (CPC).

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