Latest Update Clozapine Risk Evaluation and Mitigation Strategy (REMS) Advisory Committee Meeting 2024 April 25, 2024 – FDA will be hosting an in-person advisory committee meeting […]

The FDA Office of Generic Drugs implements the GDUFA Regulatory Science Research Program by collaborating within FDA as well as externally through grants or contracts.  Contracts […]

CDER research is helping to inform how peptide and protein therapeutics that are not monoclonal antibodies should be regulated. Background and scientific challenge The most common […]

On This Page Date: June 6, 2024 Time: 9:30 AM – 10:40 AM ET Description The Food and Drug Administration (FDA or the Agency) is announcing […]

[embedded content] Español Learn more about why you may not need antibiotics when you’re sick and the problems antibiotics can cause if taken unnecessarily. Antibiotics are […]

To illustrate the unique value of CDER’s regulatory science investments we have developed a series of “impact stories” that describe recent  advances by our researchers and […]

COMMITTEE’S OFFICIAL DESIGNATION Pharmacy Compounding Advisory Committee AUTHORITY The Pharmacy Compounding Advisory Committee (the Committee) is required by section 503A and section 503B of the Federal […]

Tianeptine is not approved by the U.S. Food and Drug Administration for any medical use. Despite that, some companies are illegally marketing and selling products containing […]

Accuracy and integrity of establishment registration and drug listing data are essential to FDA’s mission. Several key programs inside and outside the agency such as inspections, […]