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Operation Warp Speed For Rare Diseases? US FDA Is Considering Pilot Programs

 
• By Brenda Sandburg

CBER director Peter Marks says the FDA may evaluate giving gene therapy products the ‘degree of responsiveness’ that COVID-19 vaccines received. In a discussion of the pandemic's effects on staff retention, CDER director Patrizia Cavazzoni says attrition rates are back to historical levels.

Warp speed
US FDA may conduct pilot programs applying the Operation Warp Speed approach to gene therapy products. • Source: Shutterstock

The US Food and Drug Administration may conduct pilot programs to assess the value of extending its speedy approach to the review of COVID-19 vaccine candidates to gene therapy and other products.

Center for Biologics Evaluation and Research director Peter Marks noted that the center is considering such an initiative at the FDA's recent Regulatory Education for Industry Conference

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