The Regenerative Medicine Advanced Therapy (RMAT) designation, established by the 21st Cure Act in late 2016, offers similar benefits to the FDA's breakthrough therapy designation (BTD), including increased communication during development through early interactions with the agency, guidance and organizational commitment. The RMAT is designed for cell and tissue therapies for serious illness with preliminary evidence of an effect on unmet medical needs.
Use the search box to filter the chart data. Click on column headers to sort the information. Use the tabs below to switch between the RMAT list and FDA’s most recent tally of requests and awards.
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