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Gene Therapy Guidances From US FDA Coming In About 6 Weeks, Gottlieb Says

 
• By Brenda Sandburg

Potential accelerated approval endpoints will be addressed; FDA Commissioner expects gene therapy to become a 'backbone' treatment as antibodies are now.

Scott Gottlieb speaking at Financial Times US Healthcare & Life Sciences Summit
Financial Times Senior US Business Correspondent David Crow and FDA Commissioner Scott Gottlieb • Source: Brenda Sandburg

US FDA Commissioner Scott Gottlieb noted that the agency will be issuing a suite of guidances for the development of gene therapies in about six weeks.

During a keynote interview at the Financial Times US Heathcare & Life Sciences Summit in New York May 10, Gottlieb was asked what the agency is doing to spur the development of curative gene therapies

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