On November 19, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable […]

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

The public posting of a surrogate endpoint (SE) table for both reasonably likely and validated SEs was mandated by the 21st Century Cures Act of 2016 […]

Date and Time: Thursday, February 13, 2020 8:30 AM -5:30 PM GMT (livestream available on day one only) Friday, February 14, 2020 8:00 AM – 2:00 […]

What is DCAP? In 2017, FDA announced the Drug Competition Action Plan (DCAP) to further encourage robust, timely market competition for generic drugs and help bring […]

Keynote with Sally Choe Sally Choe, Ph.D.Director of the Office of Generic Drugs Pre-ANDA Program Update Karen Bengtson Office of Research and Standards (ORS) Office of Generic […]

Complex generic products are typically harder to develop, which means that many complex products face less competition than other products, and therefore can be more expensive […]

Search NDC What are the NDC Number and the National Drug Code Directory? Section 510 of the Federal Food, Drug and Cosmetic Act (Act), 21 U.S.C. […]

Action Today, the U.S. Food and Drug Administration (FDA) approved Redemplo (plozasiran) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome […]