Description of CBER’s Rare Disease Program, including a description of the program, selected activities, examples of collaborations internal and external to CBER, and frequently asked questions.

CBER 2025 Orphan Approvals (new BLAs)

On March 11, 2025, Liaoning Cheng Da USA Inc. of San Gabriel, California is recalling Hot Pot Sauce Because it may contain undeclared peanut, soy, sesame, and wheat. People who have an allergy or…

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

New Age International Inc of Brooklyn, NY is recalling all lots of Daily Veggies brand Enoki Mushroom, 200g, Product of Korea, because they may be contaminated with Listeria monocytogenes, an organism which…

As a precautionary measure, the following lots of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) have been voluntarily withdrawn by the manufacturers due to a higher rate…

New York Wholesale Group of Hicksville, NY is recalling Zaarah Herbals Rasayan Churan, Zaarah Herbals Gurmar Powder, Zaarah Herbals Vasaka Powder, and Zaarah Herbals Bhringraj Powder to the consumer/user…

This is the SOPP Section 8400: Marketing Applications main page.

The FDA investigates foodborne illnesses for human foods and animal foods. FDA’s Vet-LIRN program can help your vet determine if the illness is a result…

Certain UV wands may cause injuries within seconds and alternative disinfection methods should be used. The FDA issued a safety communication alerting consumers about these…