The Center for Biologics Evaluation and Research (CBER) regulates allergenic products. There are currently three types of allergenic products licensed for use: allergen extracts, allergen patch tests, and antigen skin tests.
Allergen extracts are used for the diagnosis and/or treatment of allergic diseases such as allergic rhinitis ("hay fever"), allergic sinusitis, allergic conjunctivitis, bee venom allergy and food allergy. Currently, there are two types of licensed allergen extracts:
- Injectable allergen extracts are used for both diagnosis and treatment and are sterile liquids that are manufactured from natural substances (such as molds, pollens, insects, insect venoms, and animal hair) known to elicit allergic reactions in susceptible individuals. Injectable allergen extracts for food allergies are used only for diagnostic purposes. Among the injectable allergen extracts, some are standardized; for these products there is an established method to determine the potency (or strength) of the product on a lot-by-lot basis. For the other injectable allergen extracts there is no measure of potency, and these are called "non-standardized."
- Sublingual allergen extract tablets are used for treatment only and are also derived from natural substances known to elicit allergic reactions in susceptible individuals, and are intended for the treatment of allergic rhinitis with or without allergic conjunctivitis.
Allergen Patch Tests
Allergen 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 nickel, rubber, and fragrance mixes) that are known to cause contact dermatitis.
Antigen Skin Tests
Antigen skin tests are diagnostic tests injected into the skin to aid in the diagnosis of infection with certain pathogens.
Report of Scientific and Medical Literature
- Federal Register Notice: Center for Biologics Evaluation and Research Report of Scientific and Medical Literature and Information on Non-Standardized Allergenic Extracts in the Diagnosis and Treatment of Allergic Disease; Extension of Comment Period
- Federal Register Notice: Center for Biologic Evaluation and Research Report of Scientific and Medical Literature and Information on Non-Standardized Allergenic Extracts in the Diagnosis and Treatment of Allergic Disease, September 26, 2011
- Panel on Review of 'Allergenic Extracts Category IIIA Reclassification, Final Report, December 1983 (PDF - 3.4MB)
- Allergenics Advisory Review Panel Reports
- Federal Register Proposed Rule: Biological Products: Allergenic Extracts; Implementation of Efficacy Review, January 23, 1985 (50 FR 3082)
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