FDA is warning consumers not to purchase or use products marketed with variations of the names “Artri” or “Ortiga” due to potentially dangerous hidden active drug ingredients not listed on the product label. FDA urges consumers taking these products to immediately talk to their health care professio
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Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
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See updates from CDER on fast-moving issues and learn about CDER's work to enhance public health
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The U.S. Food and Drug Administration on Monday approved a new indication for Filspari (sparsentan) tablets for reducing proteinuria (abnormal levels of protein in the urine) in patients aged eight years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome.
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Satellite laboratories stationed inside high-volume international mail facilities at airports in Chicago, New York, Los Angeles, Miami—and now Honolulu—are one of the U.S. Food and Drug Administration’s numerous weapons in combating counterfeit and other potentially harmful drugs.
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This technical specifications document represents the Food and Drug Administration's (FDA's) current thinking on this topic.
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Discover FDA's comprehensive list of registered outsourcing facilities engaged in human drug compounding. Get the latest updates, compliance guidelines, and resources to ensure safe, high-quality compounded medications. Explore regulations and stay informed with verified facility details.
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FDA's annual public meeting and opportunity for public comment on “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments” will be held on June 23, 2026
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Guidance Documents for Rare Disease Drug Development
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Learn about the FDA's Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) designed to curb opioid misuse by ensuring safe prescribing, dispensing, and patient monitoring practices. This initiative targets healthcare professionals and aims to improve patient safety and opioid education.
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On Wednesday, April 29, 2026, the FDA is hosting a free public webinar to provide updates on RCT-DUPLICATE, one of FDA’s demonstration projects addressing key methodological challenges in studies using real-world data (RWD).   
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FDA/CDER SBIA Chronicles, the bi-monthly newsletter of the CDER Small Business and Industry Assistance team, provides industry with useful information to assist in all aspects of drug marketing and regulation
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