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Last updated 1 day ago
Internet Pharmacy Warning Letters
1 day ago
Rogue online pharmacies offer potentially dangerous prescription drugs to U.S. consumers. FDA...
Innovative Science and Technology Approaches for New Drugs (ISTAND) Program Submission Process
1 day ago
The 21st Century Cures Act formally established a multi-step process for Drug...
FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
1 day ago
The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral...
Pediatric Exclusivity Granted
3 days ago
Approved active drugs with sponsors to which FDA has granted exclusivity for...
CDER Manual of Policies & Procedures | MAPP
3 days ago
CDER's Manual of Policies and Procedures (MAPPs) are federal directives and documentation...
FDA Approves First Oral Therapy that Inhibits Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) to Lower Bad Cholesterol in Adults with High Cholesterol
3 days ago
FDA has approved Lipfendra (enlicitide) as a treatment to be used with...
Safe Drug Use After a Natural Disaster
3 days ago
Information on the use of medicines that may be affected by fire...
Natural Disaster Preparedness and Response | Drugs
3 days ago
Stay informed on FDA's guidance for drugs used in natural disaster preparedness...
FDA/Duke-Margolis Institute for Health Policy Virtual Public Meeting: Innovation in Quantitative Medicine Summit - 09/01/2026
4 days ago
The Duke-Margolis Institute for Health Policy and the U.S. Food and Drug...