The Food and Drug Administration (FDA) has released draft guidance for the industry on using Artificial Intelligence (AI) to aid in regulatory decisions for drugs and biological products. This guidance explains how AI can be used to produce credible information or data regarding the safety, effectiveness, or quality of these products. It emphasizes a risk-based assessment framework for AI models and encourages early consultation with the FDA to ensure compliance and credibility. The guidance and its proposed recommendations are open for public comment until April 7, 2025, allowing stakeholders to contribute their views on the outlined framework and engagement options with the FDA.
Simple Explanation
The FDA wants to help people use smart computers to check if medicines are safe and work well. They are telling people how to do this and are asking everyone to share their thoughts until April 2025.