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Andrew Jonathan Hillman on Muck Rack

Andrew Jonathan Hillman

Dallas
As seen in: Trending News (Podcast), Medium, Issuu, ResearchGate, Substack, Faith Alive Podcast (2), The Hillman Letter Podcast
Covers:  Healthcare Compliance; FDA Regulatory Pathways; Biologics; False Claims Act; Expert Witness Practice

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Andrew Jonathan Hillman’s Biography

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Author of The Hillman Letter on Substack and healthcare regulatory essays on Medium. Andrew Jonathan Hillman writes on FDA Section 351(a) vs 361 pathways, Medicare overpayment rules, and federal litigation compliance.

Andrew Jonathan Hillman’s Journalist Portfolio

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The Hillman Letter | Substack

The Hillman Letter | Substack

Healthcare compliance and expert-witness insight from Dallas. By Andrew Hillman. Not an attorney, not legal a…

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Andrew Jonathan Hillman - Medium

Andrew Jonathan Hillman - Medium

Read writing from Andrew Jonathan Hillman on Medium. Dallas senior paralegal and healthcare compliance expert…

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The Hillman Letter Podcast

The Hillman Letter Podcast

How To Podcast · Plain English episodes from Andrew Hillman, Dallas, a Senior Paralegal and healthcare compli…

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The Hillman Letter Podcast (Spotify)

The Hillman Letter Podcast (Spotify)

Podcast · Andrew Jonathan Hillman · Plain English episodes from Andrew Hillman, Dallas, a Senior Paralegal an…

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Last Part Standing

Last Part Standing

Last Part Standing - Kindle edition by Hillman, Andrew Jonathan, Levine, Beverly. Download it once and read i…

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Your AI Billing Audit Tool Just Started the 60-Day Clock

Your AI Billing Audit Tool Just Started the 60-Day Clock

Your AI Billing Audit Tool Just Started the 60-Day Clock Federal rules now tie the overpayment deadline to th…

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Articles

The Biology Is Rarely What Stalls a Biotech’s First FDA Filing. The Chemistry Is.

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By Andrew Jonathan Hillman
| Medium
The Biology Is Rarely What Stalls a Biotech’s First FDA Filing. The Chemistry Is. What CBER looks for in a Pre-IND package, and why chemistry, manufacturing and controls deserves more of your prep than the science deck. Press enter or click to view image in full size Most founders walk into their first FDA meeting ready to defend the science. The mechanism. The animal data. The slide with the beautiful curve. Then the agency’s written questions come back, and many of them are about manufacturing.
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Your State Said Yes to Stem Cells. The FDA Did Not.

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By Andrew Jonathan Hillman
| Medium
Your State Said Yes to Stem Cells. The FDA Did Not. A wave of 2025 and 2026 state laws now permits unapproved regenerative therapies. Federal law did not move, and the Supreme Court let it stand. Press enter or click to view image in full size Picture a clinic owner in 2026. Her state just passed a law that expressly lets physicians offer stem cell therapy the FDA has not approved. She reads the statute, builds her consent form, buys product from a registered facility and follows every line.
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Lawyers Know the Statute. They Hire an Operator to Explain How the Business Actually Ran.

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By Andrew Jonathan Hillman
| Medium
Lawyers Know the Statute. They Hire an Operator to Explain How the Business Actually Ran. What a healthcare operator expert witness does, why the 2023 change to Rule 702 raised the bar, and the eight things counsel should send first. Press enter or click to view image in full size Let me start with what I am not. I am not an attorney. I do not give legal advice, and I do not tell a jury whether a claim was false. So why does counsel call? Because a healthcare case is rarely just about the law.
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