Quality and Regulatory Predictability: Shaping USP Standards
On This Page Date: December 11, 2025 Time: 9:00 a.m. – 10:30 a.m. ET Register HereVisit CDER Small Business and Industry Assistance (SBIA) HomepageAbout this Event (Hosted by CDER SBIA)By hosting this workshop, the Association for Accessible Medicines (AAM),...Financial Transparency and Efficiency of PDUFA, BsUFA, and GDUFA
On This Page Date: September 30, 2025 Time: 9:30 a.m. – 10:40 a.m. ET Location: Event Location White Oak Campus: The Great Room FDA Headquarters10903 New Hampshire AvenueBldg. 31, Great Room Conference CenterSilver Spring, MD 20993-0002United States...Early Alerts communicate potentially high-risk removals or corrections
On November 21, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot to minimize the time between the FDA’s initial awareness of a potentially high-risk medical device removal or correction and the agency’s public communication of what...Some Homeopathic Products May Put You at Risk
Consumers may use various types of unapproved drugs, such as homeopathic products, to treat or relieve different diseases and conditions. These products are often marketed as natural alternatives to approved prescription and nonprescription products and are widely...Update on Alert: Infusion Set Performance Issue from BD
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause...All Drug Purchases Are
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