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; Availability

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The Food and Drug Administration (FDA) is announcing the availability of its report of scientific and medical literature and information concerning the use of non-standardized allergenic extracts in the diagnosis and treatment of allergic disease. The report is provided in a data file entitled "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." FDA is making this report available to provide information and obtain comments from public and private stakeholders. FDA will also seek input on the report from the Allergenic Products Advisory Committee (APAC) at a meeting to be held on October 25, 2011. FDA has not made any regulatory decisions concerning the report or the products discussed in the scientific literature and information cited. FDA will review comments and other information it receives, as part of its continued oversight of regulated products.