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About CBER

by | May 13, 2025 | News

The Center for Biologics Evaluation and Research (CBER) is one Center within the Food and Drug Administration, an Agency within the United States Government’s Department of Health and Human Services (HHS).CBER’s mission is to protect and enhance the public...

Development & Approval Process (CBER)

by | May 12, 2025 | News

Image The Center for Biologics Evaluation and Research (CBER) regulates products under a variety of regulatory authorities including the Public Health Service Act and the Food Drug and Cosmetic Act.Related Information Content current as of: 08/04/2023...

Allergenics

by | May 12, 2025 | News

Allergen Patch TestsAllergen patch tests are diagnostic tests applied to the surface of the skin. Patch tests are used by healthcare providers to determine the specific cause of contact dermatitis, and are manufactured from natural substances or chemicals (such as...

IXCHIQ

by | May 12, 2025 | News

STN: 125777Proper Name: Chikungunya Vaccine, LiveTradename: IXCHIQManufacturer: Valneva Austria GmbHIndication:For the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to...