Glossary

Key terms, defined plainly. Part of the Andrew Hillman Advisory resources.

351(a) BLA: A Biologics License Application under section 351(a) of the Public Health Service Act, the full approval pathway for a biologic.
RMAT: Regenerative Medicine Advanced Therapy, an FDA designation that can expedite eligible regenerative therapies.
510(k): A premarket submission demonstrating a medical device is substantially equivalent to a legally marketed device.
Pre-IND: An early meeting with the FDA to align on a development plan before an Investigational New Drug application.
Capital Allocation: The disciplined deployment of capital across opportunities to maximize long-term value.
Board Observer: A non-voting seat that provides counsel and visibility at the board level.
Diligence: Independent review of a company, thesis, or transaction before investment.
Operating Discipline: The cadence and controls that turn a strategy into a functioning company.