FDA Advisory Committees - FDA Center for Drug Evaluation and Research (CDER) - Nonprescription Drugs Advisory Committee (NDAC)
Nonprescription Drugs Advisory Committee (NDAC)
The Nonprescription Drugs Advisory Committee (NDAC) reviews and evaluates available data concerning the safety and effectiveness of over-the-counter (nonprescription) human drug products, or any other FDA-regulated product, for use in the treatment of a broad spectrum of human symptoms and diseases and advise the Commissioner either on the promulgation of monographs establishing conditions under which these drugs are generally recognized as safe and effective and not misbranded or on the approval of new drug applications for such drugs. The Committee will serve as a forum for the exchange of views regarding the prescription and nonprescription status, including switches from one status to another, of these various drug products and combinations thereof. The Committee may also conduct peer review of agency sponsored intramural and extramural scientific biomedical programs in support of FDA's mission and regulatory responsibilities.