FDA Advisory Committees - FDA Center for Drug Evaluation and Research (CDER) - Nonprescription Drugs Advisory Committee (NDAC)
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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.
In the Agency’s document entitled “Food Handler Antiseptic Drug Products for Over-the-Counter Human Use; Request for Data and Information” (December 7, 2018, 83 FR 63168) (Docket No. FDA-2018-N-3458), FDA sought input on the current use of over-the-counter antiseptics in the food handler setting and the recommended testing criteria to establish the safety and effectiveness of these products. Now that the comment period has closed, FDA plans to hold an advisory committee meeting to review the information submitted and discuss its key points.
UPDATED INFORMATION FROM THE FDA (as of 3/9/2020): “Due to extenuating circumstances, the Nonprescription Drugs Advisory Committee scheduled for March 11, 2020 is being postponed until further notice.” Presumably the postponement is related to concerns about the COVID-19 virus epidemic.