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  1. Human Drug Advisory Committees

Drug Safety and Risk Management Advisory Committee

Meeting materials from 2020 and older are archived and can be accessed using the following hyperlinks:  2020, 2019, 2018, 2017, 2016, 2015, 2014, 2013, 2012, 2011, 2010, 2009, materials prior to 2009

Purpose

The Committee advises the Commissioner of Food and Drugs on risk management, risk communication, and quantitative evaluation of spontaneous reports for drugs for human use and for any other product for which the Food and Drug Administration has regulatory responsibility. The Committee also advises the Commissioner of Food and Drugs regarding the scientific and medical evaluation of all information gathered by the Department of Health and Human Services and the Department of Justice with regard to safety, efficacy, and abuse potential of drugs or other substances, and recommends actions to be taken by the Department of Health and Human Services with regard to the marketing, investigation, and control of such drugs or other substances.

Committee Membership

The Committee shall consist of a core of 11 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in risk communication, risk management, drug safety, medical, behavioral, and biological sciences as they apply to risk management, and drug abuse. 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

LCDR Michael Gu
Acting Designated Federal Officer (DFO)
Division of Advisory Committee and Consultant Management
Office of Executive Programs
E-mail: DSaRM@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.

Resources

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.

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