The regulator's map
A new medicine takes years to reach a pharmacy. Who checks it, and when?
IND: the request to start testing in people. NDA (drugs) or BLA (biologics, made from living cells): the request to sell.
1. Pick a stage
2. How fast does it go?
Slide from a fast to a slow program.
Meeting clocks
Click a row.
Talking to FDA about a new design
FDA's Complex Innovative Trial Design (CID) paired meeting program is where sponsors discuss designs such as Bayesian ones with FDA staff.
Designs are usually agreed at an end-of-phase-2 meeting (Type B) or a Type C meeting. The clocks above apply.
Who answers for the trial?
Click CRO. A dashed arrow shows who still oversees the trial.
Why the rules exist
Click a dot, or press Play.
The document shelf
Twelve public documents regulators use. Click one, or quiz yourself.
Drafts can still change. "Revised draft" means FDA reissued an earlier draft.
AI model risk
FDA's draft for AI tools used in drug decisions rates model risk from two factors. Try the toggles.
Our simple picture. The guidance names the two factors, not this grid.
Predict, then check
Regulator's corner
FDA says a Type A meeting is for a program that is stuck:
"necessary for an otherwise stalled drug or biological product development program to proceed or to address an important safety issue."
Section III. FDA, Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (August 2026).
Takeaway
- The road has stages, and FDA checks in at each big step.
- Pick the meeting that fits the question: stuck, early, or small.
- The sponsor oversees the trial, even when a CRO does the work. The CRO answers for the duties it took over in writing.