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FDA's Much Anticipated New Cell and Gene Therapy Guidance Outlines a Conservative Approach to Manufacturing Changes | King & Spalding

Published: July 28, 2023

Biologics have long been defined by their processes, raising complicated questions about how to assess the effect of manufacturing changes on product quality—i.e., whether pre- and...

Source: jdsupra.com

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Detailed text transcripts for TV channel - MSNBC - 20130811:14:01:00

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