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 […]

OMB Control Number: 0910-0929Expiration Date: 06/30/2027 The National Survey on Numerical Claims in Prescription Drug Advertising is designed to assess how adults interpret different claims used […]

[6-20-2024] The Food and Drug Administration is advising consumers not to purchase or use Infla-650, a product promoted and sold for pain on various websites, including www.nutraherbusa.com, […]

Recognized Interpretive Criteria Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Enterobacterales M100 standard is recognized Haemophilus influenzae and parainfluenzae […]

Recognized Interpretive Criteria Additional FDA-Identified Interpretive Criteria Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm) Pathogen S I R S I R Haemophilus influenzaand parainfluenzae M100 standard […]

Submit Comments by 09/20/2024 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]