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AAV Gene Therapy Panel Shined Light On Safety Issues That Sponsors Have Downplayed – FDA’s Bryan

 
• By Sue Sutter

September advisory committee was less about getting advice and more about calling public attention to AAV gene therapy safety issues, OTAT director Wilson Bryan says. FDA is not ready to set a cap on vector dose but could consider doing so down the road.

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An FDA panel meeting brought transparency to a host of safety issues that FDA believes gene therapy companies have downplayed. • Source: Alamy

The US Food and Drug Administration’s recent advisory committee meeting on adeno-associated virus (AAV) vector-based gene therapies succeeded in bringing transparency to safety issues that have troubled the field and resulted in the scientific community taking a “hard look” at such toxicities, Office of Tissues and Advanced Therapies director Wilson Bryan said.

The two-day meeting in September of the Cellular, Tissue and Gene Therapies Advisory Committee was less about getting advice and more about calling attention to AAV gene therapy safety...

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