The Hillman Letter
The R3 Medical Warning Letter Is a Pattern, Not a Mood
What operators should extract from FDA warning-letter patterns in regenerative clinics.
The Same Surgical Procedure Loophole Is Closed. Here Is What the Cell Surgical Network Injunction Means for Everyone Building a Cell or Exosome Product.
Eight years, one reversal, and a nine-page order that ends the argument.
The Permission Gap
Twelve states rewrote regenerative medicine law in eighteen months. Federal law did not move. Here is what that costs you.
Direct Biologics kills ExoFlo perianal fistula trial after enrolling five patients
Direct Biologics terminated its ExoFlo trial in perianal fistula (NCT05836883) on August 11.
The CMC chasm. Why most biotech IND submissions fail at chemistry, not biology.
The biology is usually right. The chemistry, manufacturing, and controls package is where most IND submissions fail.
Full archive on thehillmanletter.substack.com.
The NextMed Settlement Is a Roadmap. Read It Before You Build the Next Telehealth Brand.
The FTC just handed the telehealth industry an inspection checklist.
The Specific Pattern That Killed Five Biotech Programs I Personally Watched
The pattern was the same across five programs. In case you are running one of the next ones.
Why Dallas Is Quietly Becoming the Right Place to Build FDA-Regulated Biotech
The Dallas-Fort Worth biotech ecosystem has been compounding for three decades.
The 351 vs 361 Decision That Kills Most Exosome Programs
Why most exosome programs pick the wrong FDA pathway, and what the BLA route actually demands.
Why Family Office Capital Fits FDA-Regulated Biotech Better Than Venture Money
A ten-year venture fund has to return capital on a schedule. The FDA does not care about your schedule.
The Six Documentation Patterns That Show Up Before Federal Healthcare Enforcement
Every enforcement action I have served on involved a pattern visible eighteen to thirty-six months before.
What Thirty Years of Operating in FDA-Regulated Healthcare Actually Taught Me
Five lessons I would tell my younger self if I could.