Publications

When RMAT designation actually helps you. And when it is a marketing pin.

Author: Andrew Jonathan Hillman (ORCID 0009-0001-5396-321X)
Published: , Zenodo. Also published in The Hillman Letter.
DOI: 10.5281/zenodo.23352274 (all versions); this version 10.5281/zenodo.23352275
License: CC BY 4.0

Abstract

Explains Regenerative Medicine Advanced Therapy designation under 21 USC 356(g) and the conditions under which it gives real regulatory benefit. Contrasts programs that gain from the designation with those where it adds little.

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

Read the PDF on ZenodoPermanent DOI recordRead on The Hillman LetterOpenAlex record

Indexed in OpenAlex under author A5139488776.

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