Publications

The Permission Gap

Author: Andrew Jonathan Hillman (ORCID 0009-0001-5396-321X)
Published: , Zenodo. Also published in The Hillman Letter.
DOI: 10.5281/zenodo.23352290 (all versions); this version 10.5281/zenodo.23352291
License: CC BY 4.0

Abstract

Surveys state statutes enacted between May 2025 and June 2026 that permit physicians to administer stem cell and regenerative products not approved by FDA. Compares the state frameworks and explains why federal drug and biologics law still applies to the products. Not legal advice.

Exosome, stem cell and extracellular vesicle products discussed here are not approved by the FDA for any indication. This essay describes regulatory and public records. It does not describe an available treatment, and it is not legal advice.

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

Indexed in OpenAlex under author A5139488776.

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