The proposal could affect telehealth services that rely on outside facilities to produce the knockoff drugs in bulk.
The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
Katherine Szarama, who joined the FDA last year to serve as Vinay Prasad’s deputy, will now fill his shoes at CBER.
The FDA has moved to exclude semaglutide, tirzepatide and liraglutide -- which are in several popular weight loss drugs -- ...
The potential for error code confusion to cause delayed or improper treatment led the FDA to recommend users transition to ...
FDA moves to remove semaglutide, tirzepatide, and liraglutide from its 503B compounding list, saying there's no shortage of ...
The FDA released findings from its largest test on infant formula, focused on chemical contaminants and overall safety.
The US Food and Drug Administration (FDA) recently issued three warning letters to facilities in China, the US, and India for ...
By Kamal Choudhury and Mariam Sunny April 30 (Reuters) - The U.S. Food and Drug Administration has approved Axsome ...
Bayer received an FDA Untitled Letter this week for its prostate cancer drug Nubeqa, shortly after it launched a lawsuit ...
The Food and Drug Administration (FDA) has placed a hold on the enrollment of new patients in the phase 3 ENIGMA-TRS 2 study evaluating evenamide in treatment-resistant schizophrenia.