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ASGCT Supports NIH/RAC Recommendation

ASGCT Staff - August 30, 2018

While the RAC serves a valuable role as an essential public forum for science, safety, and ethics, the current requirements for gene therapies have proven redundant.

<p><em>Image background: Rita Elena Serda, Duncan Comprehensive Cancer Center at Baylor College of Medicine, National Cancer Institute, National Institutes of Health</em></p>

The American Society of Gene & Cell Therapy (ASGCT) largely supports the National Institute of Health’s (NIH) proposed changes to remove certain regulatory responsibilities from the Recombinant DNA Advisory Committee (RAC) in relation to gene therapy products. While the RAC serves a valuable role as an essential public forum for science, safety, and ethics, the current requirements for gene therapies have proven redundant.

Safety and patient access are paramount values of ASGCT, and the Society has full confidence that the FDA’s comprehensive oversight mechanisms ensure our field can advance safely and without the current requirement for duplicative reporting.

ASGCT President Michele Calos, Ph.D. will submit a full commentary on the NIH proposal in an upcoming issue of Molecular Therapy.

UPDATE (9/21/2018): ASGCT President Michele Calos, Ph.D., published her full commentary on the recommendation to redefine the Recombinant DNA Advisory Committee in the oversight of developing gene therapies.

Lack of RAC by Michele P. Calos, Ph.D.

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