FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological …

Today, the U.S. Food and Drug Administration issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness or quality. This is the first guidance the agency has issued on the use of AI for the development of drug and biological products.
“The FDA is committed to supporting innovative approaches for the development of medical products by providing an agile, […]
FDA Proposes Framework to Advance Credibility of AI Models Used for Drug and Biological …