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  1. Committees and Meeting Materials

Nonprescription Drugs Advisory Committee

Nonprescription Drugs Advisory Committee

Meeting materials from 2015 and older are archived.
To view them, please see the
FDA Archive
Purpose

The Committee 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 advises 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 serves 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.

Committee Membership

The Committee shall consist of a core of 10 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of internal medicine, family practice, clinical toxicology, clinical pharmacology, pharmacy, dentistry, and related specialties. Members will be invited to serve for overlapping terms of up to four years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests.

Contact Information

Moon Hee Choi, Designated Federal Officer
Division of Advisory Committee and Consultant Management
Office of Executive Programs
E-mail: NDAC@fda.hhs.gov

FDA Advisory Committee Information Line
1-800-741-8138
(301) 443-0572 (local number)
Please call the Information Line for up-to-date information on meetings.

 

2011-2015 Advisory Committee meeting materials are available in the FDA Archive

 

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Contact Information

FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area)

Please call the Information Line for up-to-date information on this meeting.