Summary Company Announcement Date: November 18, 2024 FDA Publish Date: November 19, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Mislabeled with the incorrect […]

Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research and Theresa Michele, M.D., Director, CDER Office of New Drugs’ Office of Nonprescription Drugs CDER Director, […]

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 […]

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Public Law No. 116-136, 134 Stat. 281, 457) was signed into law. […]

On this page Introduction Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across […]

[embedded content] Antibiotics are powerful medications that save countless lives every day. But they’re not the answer for every illness. Antibiotics treat only some infections caused […]

On November 15, 2024, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute leukemia with a […]

On This Page Listen to the The Need for Artificial Intelligence in Pharmacovigilance and the Emerging Drug Safety Technology Program audio podcast.   Podcast Transcript Dr. Weber: […]

For Immediate Release: November 15, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Next week, […]