The REMS Public Dashboard is an interactive web-based tool that will allow for the analysis of REMS data in a user-friendly way. The intention of this […]

Login, complete evaluation, and print certificate Navigate to https://ceportal.fda.gov/ If you have an account, please login If you do not have an account, click on “Create […]

Login, complete evaluation, and print certificate Navigate to https://ceportal.fda.gov/ If you have an account, please login If you do not have an account, click on “Create […]

90 208237 Memantine and Donepezil Hydrochloride Extended-Release Capsules, 21 mg/10 mg and 28 mg/10 mg ANI Pharmaceuticals, Inc. Namzaric (Memantine and Donepezil Hydrochloride) Extended-Release Capsules 12/15/2023 […]

For Immediate Release: March 08, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

For Immediate Release: March 08, 2024 Today, the U.S. Food and Drug Administration approved a new indication for use for Wegovy (semaglutide) injection to reduce the […]

What’s New Trading partners and manufacturers can use the 3911 platform in FDA’s CDER NextGen Portal (CDER NextGen) to notify FDA of illegitimate products. Question 2 […]

 Sign up for E-mail Updates Transforming how we monitor the safety of FDA-regulated products Monitoring the safety of its regulated products is a major part of the […]

Date: January 22, 2016 What is an advisory committee? Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products […]