Stakeholders Seek Clarification of RMAT Eligibility Criteria

Biocom and Gilead Sciences asked the FDA for clarification on eligibility criteria for its Regenerative Medicine Advanced Therapy designation in comments on the agency’s draft guidance, while industry trade groups requested more data on the success of the program.

The RMAT designation — which includes the benefits of the agency’s breakthrough and fast-track designations, but does not require evidence of the drug being a substantial improvement over existing therapies — was created by the 21st Century Cures Act to accelerate the review of regenerative therapies like tissue engineering products, human cell and tissue products, cell therapies and combination products.

Biocom recommended the guidance “provide greater clarity on the level of evidence required for RMAT designation” compared to breakthrough and fast-track designations.