FDA Advisory Committees - FDA Center for Drug Evaluation and Research (CDER) - Nonprescription Drugs Advisory Committee (NDAC)

Upcoming Meetings

Past Meetings

Featured
Nonprescription Drugs Advisory Committee (NDAC) and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee (ORUDAC)

On 9th and 10th May 2023, the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee will discuss sNDA for OPILL (norgestrel) tablet, submitted by Laboratoire HRA Pharma for nonprescription use to prevent Pregnancy.

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee ([AADPAC]) and the Nonprescription Drugs Advisory Committee (NDAC)

On Wednesday, February 15, 2023, the Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee ([AADPAC]) and the Nonprescription Drugs Advisory Committee (NDAC) will discuss a supplemental new drug application (sNDA- 208411/S–006) for NARCAN (naloxone hydrochloride) nasal spray, 4 mg/0.1 mL, submitted by Emergent BioSolutions Inc proposed for nonprescription treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. The issues for discussion will be on the adequacy of the data supporting the nonprescription application. NARCAN represents a potential first in class product in a new therapeutic category for nonprescription drugs.

POSTPONED: Nonprescription Drugs Advisory Committee

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.

Nonprescription Drugs Advisory Committee

The committee discussed a new drug application (NDA) by GlaxoSmithKline Consumer Healthcare Holdings for over-the-counter (OTC) nicotine mouth spray (NMS). A narrow majority of the committee, eight of fifteen committee members, voted that the data submitted in the NDA provide substantial evidence of efficacy of NMS as a smoking cessation aid in the OTC setting. A majority of the committee, nine of fifteen committee members, voted that the data provide substantial evidence of safety of OTC use of NMS. A majority of the committee, nine of fifteen committee members, voted that the risk/benefit profile of NMS is supportive of OTC use of NMS as a smoking cessation aid.

Nonprescription Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee

The Committees did not support, by a vote of 5-Yes to 15-No, with no abstentions, that the combination of an analgesic with an antacid is a rational combination for the over-the-counter (OTC) use to relieve minor aches and pains associated with heartburn, sour stomach, acid indigestion, fullness, belching, gas, or nausea. The Committees also expressed concerns with the hangover indication of several OTC monographs.

Nonprescription Drugs Advisory Committee

The Committee unanimously supported, by a vote of 16-Yes to 0-No, with no abstentions, the over-the-counter (OTC) marketing of Differin (adapalene gel 0.1%) by Galderma Laboratories, L.P. (Galderma) for the treatment of acne in consumers ages 12 years and older.

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.

FDA Committee Website