In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these...

As use of artificial intelligence and machine learning (AI/ML) in medicine continues to grow, regulators face a fundamental problem: After evaluating a medical AI/ML technology and deeming it safe and effective, should the regulator limit its authorization to market only the version of the...