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 ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

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 ...

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 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 ...

The Food and Drug Administration has been meeting with OpenAI to discuss the agency’s use of AI, according to sources with knowledge of the meetings. The meetings appear to be part of a broader effort ...

Forbes contributors publish independent expert analyses and insights. Greg Licholai writes and teaches about innovation in healthcare. We are on a bureaucratic trajectory where American leadership in ...