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Gene Therapy Guidance From US FDA Likely Needs Updating Sooner Rather Than Later

 
• By Derrick Gingery

CBER Director Peter Marks says the "half-life" for the existing six gene therapy guidances likely is two to three years due to the fast pace of scientific discovery.

Genetic Medicine with dna isolated on white.3d rendering

Gene therapy sponsors should not expect the US FDA's latest guidances to maintain a long useful life.

The suite of draft guidances issued in July likely will need to be updated within five years, which is mostly attributable to the innovation in the field, said Center

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