On This Page Date: September 12, 2024 Time: 8:45 AM – 4:45 PM ET Agenda Visit CDER Small Business and Industry Assistance Page ABOUT THIS CONFERENCE […]

Your pharmacist can help you learn how to use your prescription and nonprescription (over-the-counter) medicines safely and effectively. You can also use these tips when talking […]

[embedded content] Español The pollen count is sky-high. You’re sneezing, your eyes are itching, and you feel miserable. Seasonal allergies are real diseases that can interfere […]

abiraterone   2D6  moderate  inhibitor                 acyclovir     1A2  weak  inhibitor               […]

Drug Shortages: Root Causes and Potential Solutions, published in October 2019, examines the underlying factors responsible for drug shortages and recommends enduring solutions. The inter-agency Drug […]

Action The U.S. Food and Drug Administration has approved Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Vyvgart […]

In 2017, CDER began the modernization of the New Drugs Regulatory Program (NDRP), a multi-year framework to increase the efficiency and effectiveness of CDER offices. The […]

On June 21, 2024, the Food and Drug Administration granted accelerated approval to adagrasib (Krazati; Mirati Therapeutics, Inc.) plus cetuximab for adults with KRAS G12C-mutated locally […]

Date: July 22, 2024 Time: 9:00 AM – 2:00 PM ET Background Efficient and effective reviews of marketing applications are an important part of FDA’s mission […]