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                Genetic Metabolic Diseases Advisory Committee

Genetic Metabolic Diseases Advisory Committee
              
                        Genetic Metabolic Diseases Advisory Committee (GeMDAC) Charter Home
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          Genetic Metabolic Diseases Advisory CommitteeHuman Drug Advisory Committees Genetic Metabolic Diseases Advisory Committee
	
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FDA is accepting nominations for the Genetic Metabolic Diseases Advisory Committee until February 11, 2024. For information on how to submit a nomination, please visit FDA Advisory Committee Membership Nomination Portal.


Purpose

The Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational human drug and biologic products for use in the treatment of genetic metabolic diseases and makes appropriate recommendations to the Commissioner of Food and Drugs.

Committee Membership

The Committee shall consist of a core of nine voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of medical genetics, manifestations of inborn errors of metabolism, small population trial design, translational science, pediatrics, epidemiology, or statistics and related specialties. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who serves as an individual but 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 representative member who is identified with industry interests.

Contact Information

**Moon Choi, PharmD 
Designated Federal Officer (DFO)**
Division of Advisory Committee and Consultant Management 
Office of Executive Programs 
E-mail: GeMDAC@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.

How to apply to become a member

The FDA is looking to solicit views from technical and scientific subject matter experts from diverse disciplines and backgrounds, including both women and men, members of all racial and ethnic groups, and individuals with and without disabilities, for this advisory committee and, therefore encourages nominations of appropriately qualified candidates from these groups.

For those interested in serving or nominating a representative to serve as a voting or non-voting member of the FDA's Genetic Metabolic Diseases Advisory Committee, please either submit your nomination electronically by accessing the FDA Advisory Committee Membership Nomination Portal or by mail to:

Advisory Committee Oversight and Management Staff
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 32, Rm. 5103
Silver Spring. 20993-0002.

**Nominations should be submitted no later than February 11, 2024, for industry representatives, consumer representatives, and voting members.**

Applications should include a current, complete résumé or curriculum vitae for each nominee, including a current business and home address, telephone number, and e-mail address if available.

Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA Advisory Committees.

Resources

FDA Creates New Advisory Committee for Evaluation of Genetic Metabolic Disease Treatments
	Drug Products Committee VacanciesFederal Register Notices

Establishment
	Requests for Consumer Nominations
	Request for Industry Nominations
	Request for Academic/Clinical Voting Members
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.**

                                                                                  Content current as of:
      12/13/2023Genetic Metabolic Diseases Advisory Committee
              
          
                        Genetic Metabolic Diseases Advisory Committee (GeMDAC) Charter
 
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