www.fdanews.com/articles/212993-genetic-metabolic-disease-drugs-to-be-explored-by-new-fda-advisory-committee

Genetic Metabolic Disease Drugs to be Explored by New FDA Advisory Committee

December 15, 2023

The FDA has announced a new Genetic Metabolic Diseases Advisory Committee (GeMDAC) to help the agency explore the complex issues related to genetic metabolic disease drug development.

GeMDAC will advise the FDA on the safety and effectiveness of human drug and biological products that are under investigation or submitted for marketing approval for use in the treatment of genetic metabolic diseases. The committee will consist of nine voting members with technical and scientific expertise from diverse disciplines and backgrounds.

Nominations or applications to serve on GeMDAC may be submitted by accessing the FDA Advisory Committee Membership Nomination Portal or by mail. Nominations should be submitted no later than Feb. 11, 2024.

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