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Pilot Phase Of Operation Warp Speed For Rare Diseases Beginning Soon

 
• By Derrick Gingery

US FDA’s biologics center intends to ask for volunteers to help demonstrate the concept, modeled on the COVID vaccine effort, which includes speedier communication with sponsors to expedite development of products for rare diseases.

Operation Warp Speed and flag
Concepts used for development of COVID-19 vaccines could be implemented to speed development of gene therapies for rare diseases. • Source: Shutterstock

A new enhanced communication program for cell and gene therapy sponsors developing products for rare diseases is nearing its pilot-stage launch.

The US Food and Drug Administration’s Center for Biologics Evaluation and Research wanted to use some of the lessons from...

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