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Genetic Metabolic Diseases Advisory Committee

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 

Yvette Waples, PharmD 
Acting 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, MD 20993-0002.

Nominations received on or before March 12, 2024, will be given first consideration for voting members. Nominations received after March 12, 2024, will be considered for nomination to the Committee as later vacancies occur.

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.

Frequently Asked Questions

When does FDA expect to fill all of the Genetic Metabolic Diseases Advisory Committee (GeMDAC) seats?

CDER is looking for a highly qualified pool of experts to fill the GeMDAC. We do not have a specific date for when all the standing members will be appointed. CDER is dedicated to a comprehensive and considerate approach to filling the committee seats promptly. As standing committee members are appointed, the roster on the GeMDAC webpage will be updated.

How do I become a member of the GeMDAC?

Any interested person may nominate one or more qualified persons for the advisory committee. Self-nominations are also accepted. You may submit your information by logging into the FDA Advisory Committee Membership Nomination Portal.

Persons nominated as scientific members must be technically qualified experts in their field (e.g., metabolic genetics, management of inborn errors of metabolism, small population trial design, translational science, pediatrics, epidemiology, statistics, and other related specialties). FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

What information are interested nominees expected to provide to evaluate possible conflicts of interest?

Potential candidates are asked to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts in order to permit evaluation of possible sources of conflict of interest. For more information view the FDA Advisory Committees: Conflict of Interest Overview.

What general resources about advisory committees are available for AC members to access?

Free, online, on-demand regulatory science learning modules that provide an overview of advisory committee meetings are available to AC members and the public on the New Drugs Regulatory Program (NDRP) Advisory Committees webpage. You may also access the FDA Advisory Committee homepage, which provides additional information on the program, upcoming meetings, and other relevant resources on FDA’s Advisory Committees.

Resources

Federal Register Notices

 

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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