The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...
Session Objectives: The IOM drug safety report recommended that the FDA receive “substantially increased resources” to support improvements in the system for ensuring drug safety and efficacy ...
Here’s how drug developers can best approach interactions with the agency following last year’s seismic changes to its leadership, workforce and policies.
Matthew Herper covers medical innovation — both its promise and its perils. On Tuesday, the Food and Drug Administration said that it would offer U.S. companies that support “U.S. national interests” ...
On Nov. 6, the Food and Drug Administration’s (FDA) Digital Health Advisory Committee (DHAC) convened to discuss the promise and evolving challenges of Generative Artificial Intelligence ...
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 ...
New FDA Leadership Team: The FDA's top leadership has shifted under Commissioner Dr. Marty Makary, with Dr. Vinayak "Vinay" Prasad now heading the Center for Biologics Evaluation and Research (CBER) ...
Food and Drug Administration (FDA) Commissioner Marty Makary on Friday announced that the agency’s top regulator Vinay Prasad ...