Peden named chair of FDA Allergenic Products Advisory Committee

The advisory committee advises the Center for Biologics Evaluation and Research at the FDA on matters, including approvals, related to allergenic products for clinical use with specific indications for allergic diseases including allergic rhinitis, asthma, food allergy, and insect allergy.

Peden named chair of FDA Allergenic Products Advisory Committee click to enlarge David Peden, MD

David B. Peden, MD, MS, the Harry S. Andrews Distinguished Professor of Pediatrics and Senior Associate Dean for Translational Research, was named chairperson of the Allergenic Products Advisory Committee, which advises the Center for Biologics Evaluation and Research at the FDA on various issues related to allergenic products for clinical, including the approval of such products.

Peden, who is the Director of the Center for Environmental Medicine, Asthma and Lung Biology, Division Chief of Pediatric Allergy, Immunology and Rheumatology at UNC School of Medicine, has been a member of the committee for several years. He will serve as chair until August 31, 2020.

The committee’s objectives and scope of activities include advising the FDA commissioner or designee to help ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory responsibility.

The committee reviews and evaluates available data concerning the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological products or materials that are administered to humans for the diagnosis, prevention, or treatment of allergies and allergic disease. It makes appropriate recommendations to the commissioner of its findings regarding the affirmation or revocation of biological product licenses, on the safety, effectiveness, and labeling of the products, on clinical and laboratory studies of such products, on amendments or revisions to regulations governing the manufacture, testing and licensing of allergenic biological products, and on the quality and relevance of FDA’s research programs, which provide the scientific support for regulating these agents.

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