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

Executive Summary

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.

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‘Warp Speed’ For Rare Diseases: Gene Therapy Pilot Also Includes Neurodegenerative Drugs

A plan developed by the US FDA biologics center to test ‘Operation Warp Speed’ style communication to support development of gene therapies is launching – and the scope has broadened to include drugs targeting ALS and other neurodegenerative diseases.

Pilot Phase Of Operation Warp Speed For Rare Diseases Beginning Soon

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.

Supplemental Filings: CBER/CDER Real-Time Comms, DCT Fall Off, Mifepristone REMS

US CBER director Peter Marks suggests CDER could join its real-time communications pilot program, CDER's Jacqueline Corrigan-Curay says the use of decentralized trials has declined since the pandemic eased, and the GAO concludes that revisions to the mifepristone REMS do not require congressional review.

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