Expert panels convened by the U.S. Food and Drug Administration (FDA) to evaluate scientific evidence and provide recommendations on regulatory decisions related to medical products’ safety and efficacy.
A determination made by the FDA regarding the approval, clearance, or marketing authorization of medical products such as drugs, biologics, and medical devices.
Evaluation of the potential risks associated with the use of a medical product, including adverse reactions, side effects, and potential harm to patients.
Examination of the effectiveness of a medical product in achieving its intended therapeutic outcomes based on clinical trial data and other relevant evidence.
Assessment of the overall benefits and risks of a medical product in terms of its potential impact on population health and patient outcomes.
Situations where the personal or financial interests of committee members may unduly influence their judgment or decision-making process, potentially compromising the integrity of the advisory committee’s recommendations.
A session during FDA Advisory Committee meetings where members of the public, including patients, advocacy groups, and industry representatives, can provide testimony or comments on the topic under discussion.
Evaluation of medical products by the FDA prior to their introduction into the market to ensure their safety and efficacy meet regulatory standards.
Ongoing monitoring of medical products once they are on the market to identify and address any safety concerns or adverse events that may arise.
The process of conveying information about the risks and benefits of medical products to healthcare professionals, patients, and the general public in a clear, transparent, and timely manner.