CGMPs for Combination Products: Understanding and Applying FDA’s Draft Guidance - Barr Weiner of FDA

Описание к видео CGMPs for Combination Products: Understanding and Applying FDA’s Draft Guidance - Barr Weiner of FDA

John Barlow “Barr” Weiner, associate director for policy and product classification in FDA’s Office of Combination Products (OCP), examines the agency’s draft guidance on current Good Manufacturing Practice (CGMP) for combination products. Weiner’s presentation was part of the workshop, CGMPs for Combination Products—Understanding and Applying FDA’s Draft Guidance: An Interactive Analysis with FDA and Industry, presented by the Regulatory Affairs Professionals Society (RAPS) and the Combination Products Coalition (CPC).

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