On November 19, 2025, the Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone […]

Resources The innovative regulatory approaches resulting from the 21st Century Cures Act are modernizing new drug development. The use of clinical trials with Master Protocol design […]

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, […]

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 […]