RMAT or BLA. When to chase Regenerative Medicine Advanced Therapy designation, and when to wait.

Hillman, Andrew Jonathan

doi:10.5281/zenodo.23352261

RMAT or BLA. When to chase Regenerative Medicine Advanced Therapy designation, and when to wait.

Author: Andrew Jonathan Hillman (ORCID 0009-0001-5396-321X)
Published: June 6, 2026, Zenodo. Also published in The Hillman Letter.
DOI: 10.5281/zenodo.23352261 (all versions); this version 10.5281/zenodo.23352262
License: CC BY 4.0

Abstract

Addresses when a 351(a) sponsor should seek Regenerative Medicine Advanced Therapy designation. Summarizes the RMAT criteria and argues the designation helps but is not a shortcut to licensure.

This essay describes FDA regulatory process for educational purposes. It is not legal or regulatory advice.

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Indexed in OpenAlex under author A5139488776.

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