How FDA Advisory Committees Influence Gene Therapy Approvals
Gene therapy is a cutting-edge field that holds great promise for treating genetic disorders. However, the approval process for these therapies is complex, and FDA advisory committees play a crucial role in evaluating their safety and efficacy. Ceres gene therapy regulatory experts help companies navigate the FDA approval process, ensuring they meet all regulatory requirements.
1. The Role of FDA Advisory Committees
FDA advisory committees are independent panels of experts that review the data submitted for gene therapy products. These committees provide recommendations to the FDA on whether a product should be approved based on its safety and effectiveness. While the FDA is not required to follow the committee’s recommendations, their input heavily influences the final decision.
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