By: Cassandra L. Taylor, public health advisor, Office of the Center Director, Center for Drug Evaluation and Research (CDER) and Schuyler Pruyn, project manager, Office of […]

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the agency’s current thinking on a topic and should be viewed only […]

We evaluated three categories of drug products for this proposed rule.  We would place all three of these categories of drug products on the Demonstrable Difficulties […]

Submit Comments by 06/20/2024 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]

For Immediate Release: March 19, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]

No. DrugName Active Ingredient Date FDA-approved use on approval date* 45. Zurampic lesinurad 12/22/2015 To treat high blood uric acid levels associated with goutDrug Trials Snapshot […]

On This Page Date: April 25, 2024 Time: 1:00 PM – 4:00 PM ET AGENDA Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT […]

Helping Guide the Way for New Medicines Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s […]

On March 19, 2024, the Food and Drug Administration granted accelerated approval to ponatinib (Iclusig, Takeda Pharmaceuticals U.S.A., Inc.) with chemotherapy for adult patients with newly […]