Andrew Hillman's 2026 paper on the line between Section 361 tissue products and Section 351(a) biologics, and why he argues Wharton's jelly exosomes belong on the 351(a) path. We cover the four criteria in 21 CFR 1271.10(a), the FDA's 2019 safety notification, the federal RMAT and Right to Try frameworks and their limits, and what manufacturing controls look like. Exosome products are not approved by the FDA for any indication. Hosted by Andrew Jonathan Hillman, Dallas, Texas. Permanent record (DOI): https://doi.org/10.5281/zenodo.21142612 Main site: https://andrew-hillman.com/ Publications: https://andrew-hillman.com/publications/ This episode is educational and is not legal or medical advice. Andrew Hillman is not an attorney. Narrated by an AI voice (synthetic narration). No real person's voice or likeness is used. Links and resources: Companion paper: https://andrew-hillman.com/publications/biologics-paradigm-351a-vs-361-hctp/ Podcast home: https://andrew-hillman.com/podcast/ About the host: https://andrew-hillman.com/who-is-andrew-jonathan-hillman/ LinkedIn: https://www.linkedin.com/in/andrew-hillman-dallas The Hillman Letter on Substack: https://thehillmanletter.substack.com Apple Podcasts: https://podcasts.apple.com/us/podcast/the-hillman-letter-podcast/id6825615190 Spotify: https://open.spotify.com/show/2ZYUBaVrUxWDAhskCNTXzs YouTube playlist: https://www.youtube.com/playlist?list=PLElpO9MC9VC4 Academia.edu, SMU: https://smu.academia.edu/AndrewHillman ORCID: https://orcid.org/0009-0001-5396-321X Wikipedia: https://en.wikipedia.org/wiki/Andrew_Jonathan_Hillman Book a call: https://calendly.com/ajhusa Educational only. Not legal advice. Not an attorney.