HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

Listen Dr. Roach: Welcome to “Q&A with FDA,” where we aim to answer some of the most frequently asked questions that we’ve received from the public. […]

On This Page Date: May 7 – 8, 2024 Day1: Tue, May 7 9:00 AM – 5:00 PM ET Day2: Wed, May 8 9:00 AM – […]

Rezdiffra (resmetirom) In conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with […]

This listing includes accelerated approvals (AAs) for non-malignant hematological, neurological, and other disorder indications with postmarketing trials that have verified clinical benefit and for which traditional approval has been […]

On This Page Date: June 13, 2024 Time: 8:50 AM – 11:25 AM ET Agenda Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT […]

CDER, CBER and CDRH Expanded Access INDs and Protocols (2019-2023) On this page you will find: The Center for Drug Evaluation and Research (CDER) and the […]

Discover training recourses available under the QM CoE. Workshop QM in Regulatory Science in Action Content current as of: 05/02/2024 Regulated Product(s)

A core value of the QM CoE is collaboration, and the primary CoE membership includes interdisciplinary experts that work in CDER. To ensure the CoE is […]