PDUFA VII: US FDA Will Offer Additional Meetings To Boost Rare Disease Endpoint Development

 
• By Derrick Gingery

If they reach a public disclosure agreement, a handful of sponsors will be admitted to a new pilot program that allows four meetings with the FDA on rare disease endpoint issues.

drug development pipeline
The RDEA pilot program will offer sponsors additional help from the FDA on novel rare disease endpoints. • Source: Alamy

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