FDA guides and templates.

A simple guide to who decides whether your tissue product is regulated solely under section 361 of the Public Health Service (PHS) Act, and where it lands inside FDA if it isn’t.

How FDA actually enforces the HCT/P regulatory framework and where companies keep going wrong.

The strongest case for eligibility is built long before the actual submission.

A successful submission effectively translates your strategy.

How cell and gene therapy biological products moves from idea to licensed BLA

A guide to the formal FDA meetings every cell and gene therapy program runs on, built on the framework that governs all drugs and biologics.

Why and when to ask FDA for early advice on a novel biologic, and how to know you’re actually ready.

INTERACT is a single, early, non-binding shot at FDA's read on a novel program. Here is how sponsors squander it, and what to do instead.

How to create a focused INTERACT submission with the right questions

A former reviewer's field guide to the seven ways sponsors waste a Pre-IND meeting, and what it takes to get concrete answers instead.

What FDA has to see in your Chemistry, Manufacturing, and Controls package to let you dose the first patient, and what can wait until later.

How to recognize a deteriorating FDA review, read the decision letter, and move quickly and carefully when a clinical hold, CRL, or NSE lands.