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Gene Therapy: Pediatric Development Could Start Sooner Than Sponsors Think – FDA OTP Director

 
• By Derrick Gingery

Nicole Verdun said children could participate in gene therapy clinical trials earlier if the necessary controls are in place.

pediatrics
The FDA may need to educate sponsors about its willingness to involve children earlier in gene therapy development. • Source: Shutterstock

Nicole Verdun would like to see gene therapy sponsors involve children earlier in development when appropriate, rather than wait until testing is completed in adults.

The director of the US Food and Drug Administration Center for Biologics Evaluation and Research’s Office of Therapeutic Products said agency officials are considering how to

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