The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...

In a landmark decision poised to revolutionize drug development, the U.S. Food and Drug Administration (FDA) has announced a new initiative to significantly reduce, refine, and replace animal testing ...

Forbes contributors publish independent expert analyses and insights. Tor Constantino is an ex-reporter, turned AI consultant & tech writer. In a landmark for U.S. public health digital transformation ...

According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a ...

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...

The FDA has qualified its first artificial intelligence tool to help drug developers evaluate fatty liver disease in their clinical trials. The agency gave a green light to the AI-Based Histologic ...