GUIDANCE DOCUMENT Draft Level 1 Guidance Not for implementation. Contains non-binding recommendations. This guidance is being distributed for comment purposes only. Content current as of: 11/25/2024 […]

Background Prescribing information (PI) included in prescription drug labeling is FDA’s primary tool for communicating a summary of the essential scientific information needed for the safe […]

UPDATE: On November 22, 2024, the FDA announced the final withdrawal of the approval of sacituzumab govitecan-hziy (Trodelvy) for adult patients with locally advanced or metastatic urothelial […]

On This Page Date: January 22, 2025 Time: 1:00 PM – 3:00 PM ET AGENDA Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT […]

Action  The U.S. Food and Drug Administration has approved Attruby (acoramidis) to treat adults with cardiomyopathy (disorder that affects heart muscle) of wild-type or variant (hereditary) […]

For Immediate Release: November 22, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, […]

[11-22-2024] The Food and Drug Administration is advising consumers not to purchase or use Force Forever, a product promoted and sold for joint pain on various […]

[11-22-2024] The Food and Drug Administration is advising consumers not to purchase or use THERMO SHOCK, a product promoted and sold for weight loss on various […]

Over 7,000 rare diseases affect more than 30 million people in the United States. Many rare conditions are life-threatening and most do not have treatments. Drug, […]