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Top US FDA Official Says New 'Playbook' Needed For CMC Reviews Of Gene Therapy Products

 
• By Joanne S. Eglovitch

CBER director says lack of a clear regulatory structure is holding back the development and acceleration of gene therapy products, while industry says regulations should be flexible to keep up with changing technology for these products.

Gene therapy
Regulator And Industry Identify "Constriction" Points In Gene Therapy Manufacturing • Source: Shutterstock

A “new playbook” is needed to ensure consistent chemistry, manufacturing, and controls (CMC) reviews for gene therapy products, the lack of which is hindering the development of these products, asserted a top official at the US Food and Drug Administration .

“Now is the time to get things right” asserted Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, who spoke at a 15 June virtual Drug Information Association annual meeting

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More from Compliance

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
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