Essays · The Hillman Letter
Long-form writing on FDA regulatory strategy, frontier therapeutics, family office capital, and healthcare compliance. Thirty years of operating experience translated into essays you can read in twenty minutes. Seven essays published. New essays weekly.
The False Claims Act, Anti-Kickback, Stark, HIPAA, EKRA, and qui tam whistleblower exposure, and the infrastructure that turns statutory knowledge into a defensible compliance record.
The FTC just handed the telehealth industry an inspection checklist.
The pattern was the same across five programs. In case you are running one of the next ones.
The Dallas-Fort Worth biotech ecosystem has been compounding for three decades.
Why most exosome programs pick the wrong FDA pathway, and what the BLA route actually demands.
A ten-year venture fund has to return capital on a schedule. The FDA does not care about your schedule.
Every enforcement action I have served on involved a pattern visible eighteen to thirty-six months before.
Five lessons I would tell my younger self if I could.