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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

Related Topics:

Peter Marks Jonathand Grinstein Drug Administration King Spalding Gene Therapy Regulation To Device Center Agency Center Biologics Evaluation Draft Guidance Manufacturing Changes Human Cellular Gene Therapy Products Human Biologics Products Investigational New Drug Application Biologics License Application Drug Admin Peter Marks Outlines Advancing Gene Therapies Pink Sheet Human Biological Products

FDA Releases CMC Postapproval Manufacturing Changes For Specified Biological Products To Be Documented In Annual Reports - Vimarsana News

FDA Releases CMC Postapproval Manufacturing Changes For Specified Biological Products To Be Documented In Annual Reports

Published: February 22, 2022

This new FDA/CDER guidance represents the FDA's thinking regarding the types of changes to an approved biologics license application (BLA) that...

Source: lifescienceleader.com