The US Food and Drug Administration review of the safety and effectiveness of nonstandardized allergen extracts

Author:

Slater Jay E.,Menzies Sandra L.,Bridgewater Jennifer,Mosquera Alexis,Zinderman Craig E.,Ou Alan C.,Maloney Diane,Cook Catherine M.,Rabin Ronald L.

Publisher

Elsevier BV

Subject

Immunology,Immunology and Allergy

Reference26 articles.

1. Allergen immunotherapy in historical perspective;Cohen;Clin Allergy Immunol,2008

2. Immunologic responses to subcutaneous allergen immunotherapy;Till;Clin Allergy Immunol,2008

3. Drug amendments of 1962. Pub L No. 87-781, 76 Stat 780.

4. Review procedures to determine that licensed biological products are safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use (2011) (21 CFR §601.25).

5. Allergenic biological products; request for data and information; safety, effectiveness, and labeling review, 39 Federal Register 1082-1083 (January 4, 1974).

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