Operation Warp Speed for Rare Diseases is on the Way
February 14, 2023
Director Peter Marks of the US Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research has announced the next stage of Operation Warp Speed, a program intended to find cures and treatments for rare diseases. The program will support drugmakers developing drugs for rare diseases and will establish close lines of communication between companies and the agency to expedite the process.
According to , “Marks stressed that he trusts his deputy Celia Witten to find new talent for the FDA’s retiring leadership as the agency transitions from its Office of Tissues and Advanced Therapies to the super-office to be known as the Office of Therapeutic Products, or OTP. He also explained how he’s looking into using a Project Orbis-like approach to expanding the approval of gene and cell therapies throughout other high-income countries (e.g. UK, Japan, EU) as the FDA’s Oncology Center of Excellence currently does for some new cancer drugs and indications.”
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(Source: Endpoints News, February 13th, 2023)
