Allergenics

The Center for Biologics Evaluation and Research (CBER) regulates allergenic products. ^[1] There are currently three types of allergenic products licensed for use: ^[2]

• Allergen extracts: used for the diagnosis and/or treatment of allergic diseases such as allergic rhinitis (this category includes injectable allergen extracts and sublingual allergen extract tablets)
• Allergen patch tests: diagnostic tests applied to the surface of the skin
• Antigen skin tests: diagnostic tests injected into the skin to aid in the diagnosis of infection with certain pathogens.

FDA Resources:

• Allergenics Guidances
• Allergenic Products Advisory Committee

Updated by Peter Matos, December 2023