FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)

This new pilot program is designed to accelerate the development and review of certain drugs and biological products that are aligned with U.S. national health priorities and to enhance the health interests of Americans.

Kenz Henz of Santa Fe, TX, is recalling its 12 count packages of “Grade AA Large Pasture Raised eggs” because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with wea

The Food and Drug Administration is advising consumers not to purchase or use VITAFER-L Gold 10ml, a product promoted for energy and sexual enhancement on various websites, including www.amazon.com.  

CDER has established a meeting program called the Emerging Drug Safety Technology Meeting (EDSTM) program. Learn more.

Category 2 of the Bulk Substances Nominated Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act

Unapproved New Drugs/Misbranded