RMAT Designation Enables Critical Manufacturing Discussions – FDA's Marks
Designation of cell and gene therapies as regenerative medicine advanced therapies is enabling deeper interaction with the US FDA on manufacturing challenges, says the head of the agency's biologics center.
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Draft guidance suggests comparing therapies for a rare disease to each other and active control, offers examples of novel efficacy endpoints and what therapies may qualify for breakthrough and RMAT designations.
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High-level board will bring together information from across FDA drug center and work to increase supply chain transparency, says CDER’s Jacqueline Corrigan-Curay.