May 2, 2024
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 […]
May 2, 2024
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 […]
May 2, 2024
At least three clients of an unlicensed spa in New Mexico contracted HIV after receiving platelet-rich plasma (PRP) microneedling facials, according to an investigation by the […]
May 2, 2024
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 […]
May 2, 2024
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 […]
May 2, 2024
The US Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of adalimumab-adbm (Cyltezo), a biosimilar of Humira, Boehringer Ingelheim announced. This high-concentration formulation […]
May 2, 2024
Noninvasive transcranial alternating current stimulation (tACS) may lead to rapid improvement in major depressive disorder (MDD), results of a randomized, sham-controlled trial suggested. However, independent experts […]
May 2, 2024
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)
May 2, 2024
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 […]
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