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 […]
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 […]
The Center for Drug Evaluation and Research (CDER) Quantitative Medicine (QM) Center of Excellence (CoE) is established to facilitate and coordinate the continuous evolution and consistent […]
On This Page Date: August 16, 2024 Time: 9:00 AM – 4:00 PM ET Meeting Location FDA White Oak CampusBuilding 31, Conference Center, The Great Room10903 […]
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