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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.

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Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
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• By Kate Rawson

A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.

US Approach To Cell And Gene Therapy Regulations ‘Less Strict’ Than EU

 
• By Eliza Slawther

Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.

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Device-Like System Proposed For Low-Risk Human Cell Therapies, Tissue-Based Products At US FDA

 
• By Kate Rawson

A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.

US Approach To Cell And Gene Therapy Regulations ‘Less Strict’ Than EU

 
• By Eliza Slawther

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• By Michael McCaughan

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