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What Are Some Hot-Button Issues for the FDA?

What Are Some Hot-Button Issues for the FDA? Having had a long career history with the FDA, David Doleski, Compliance Head for Biologics Quality Operations, Sanofi, provided his insight into the mindset of a regulator during his keynote presentation How Perspectives Change: From Regulator to Regulated at the 2020 #ISPE Aseptic Conference.

Issues

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