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Latest posts
Last updated about 10 hours ago
October 10, 2024: Meeting of the Cardiovascular and Renal Drugs Advisory Committee - 10/10/2024
about 10 hours ago
The Committee will discuss new drug application (NDA) 215244, for elamipretide hydrochloride...
Internet Pharmacy Warning Letters
about 17 hours ago
Rogue online pharmacies offer potentially dangerous prescription drugs to U.S. consumers. FDA...
Transderm Scōp (Scopolamine Transdermal System): Drug Safety Communication - FDA Adds Warning About Serious Risk of Heat-Related Complications with Antinausea Patch
about 18 hours ago
The FDA is warning that the antinausea patch Transderm Scōp (scopolamine transdermal...
Pharmaceutical Quality Resources
about 19 hours ago
FDA provides resources on pharmaceutical quality topics, including information on regulations, guidance...
News from Emerging Technology Program (ETP)
about 19 hours ago
CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote...
FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma
3 days ago
On June 18, 2025, the Food and Drug Administration approved tafasitamab-cxix (Monjuvi...
Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
3 days ago
Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors...
FDA adds warning about serious risk of heat-related complications with antinausea patch Transderm Scōp (scopolamine transdermal system)
3 days ago
The antinausea patch Transderm Scōp (scopolamine transdermal system) can increase body temperature...
Clinical Outcome Assessment (COA) Qualification Program: Frequently Asked Questions
4 days ago
CDER Clinical Outcome Assessments (COA) Qualification Program: Frequently Asked Questions (FAQs)
Qualified Clinical Outcome Assessments (COA)
4 days ago
The table below lists qualified Clinical Outcome Assessments (COA). The tables include...
FDA's ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital health technology for neuroscience
4 days ago
FDA's Center for Drug Evaluation and Research (CDER) recently accepted a new...