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

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