FDA has released a white paper outlining a potential regulatory framework for software as a medical device (SaMD) that leverages artificial intelligence (AI) or machine learning (ML). The white paper ...

The US Food and Drug Administration (FDA) Office of Pharmaceutical Quality (OPQ) of the Center for Drug Evaluation and Research (CDER) recently published a White Paper laying out a framework to ...

The FDA has documented the steps leading up to the approval of Biogen’s Alzheimer’s disease drug Aduhelm, revealing how the mixed evidence on the controversial therapy divided its staff. In its ...

Rapid scientific advances are accelerating the development of medical innovations, from personalized treatments to curative gene therapies and advanced diagnostic tools. But significant policy and ...