Pharma News Intelligence December 14, 2023
The new FDA Genetic Metabolic Diseases Advisory Committee will evaluate medical products for related conditions and provide regulatory recommendations.
Adding to the lengthy list of advisory committees under its belt, the United States Food and Drug Administration (FDA) announced its plans to create a new advisory committee to specialize in genetic metabolic disease treatments. The announcement, published on December 12, 2023, clarified that the advisory committee would fall under the Division of Rare Diseases and Medical Genetics, a subset of the Center for Drug Evaluation and Research (CDER) Office of Rare Diseases, Pediatrics, Urologic, and Reproductive Medicine (ORPURM).
FDA advisory committees play a critical role in evaluating and approving medical products. Comprised of multiple members with varying backgrounds, the committees...