One-third of all the regenerative medicine advanced therapy (RMAT) designations granted by the US Food and Drug Administration’s Center for Biologics Evaluation and Research were awarded in fiscal years 2024 and 2025, recently updated agency data shows.
Rapidly Rising RMAT Designations Crack CBER’s Communication Freeze
The US FDA is receiving more requests for regenerative medicine advanced therapy designation and granting more of them, according to recently reported agency data.
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