Gene Therapy AAV Vector Toxicities Get US FDA's Attention

Advisory committee will discuss five types of toxicity risks with adeno-associated virus vector-based gene therapy products at a two-day meeting in September, which follows some recent high-profile instances of adverse events that have delayed development programs.

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US FDA is putting the spotlight on five types of toxicities with AAV gene therapy vectors. • Source: Alamy

A US Food and Drug Administration advisory committee will turn its attention to toxicity risks of adeno-associated virus vector-based gene therapy products at an upcoming two-day meeting.

The Cellular, Tissue and Gene Therapies Advisory Committee will meet via teleconference on 2-3 September to discuss and make recommendations...

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