FDA

U.S. Food and Drug Administration

U.S. regulator for drugs, biologics, devices & combination products.

National agencyUnited StatesSilver Spring, MD, USAEst. 1906Website

Guidance & recent approvals

5 docs · 4 approvals

Warning Letter — Data Integrity Observations (illustrative)Warning letter · 2023Final

Recent approvals · illustrative

Illustrative CAR-T therapy6 mo

Demo Biologics · Relapsed/refractory lymphoma

Cell therapyBreakthrough Therapy2024-09

Illustrative mRNA vaccine8 mo

Demo Vaccines · Respiratory virus

VaccinePriority Review2024-06

Illustrative AAV gene therapy7 mo

Demo Gene Tx · Inherited retinal disease

Gene therapyAccelerated Approval2024-03

Illustrative oral small molecule10 mo

Demo Pharma · Solid tumor

Small moleculeStandard2023-11

FDA

U.S. Food and Drug Administration

National agency · USA

Live record · illustrative seed data · scores deterministic, rules-based — not AI.