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 ...

During an April 7 session of the Biopharma Congress, Janet Woodcock, MD, former acting FDA Commissioner and former principal deputy commissioner of food and drugs, called the recent FDA staff cuts a ...

The advent of artificial intelligence (AI) and data-driven methodologies has triggered a wave of transformation in regulatory compliance and quality assurance for the development of medical devices.

The majority of medical and surgical devices used to treat children are not cleared by the Food and Drug Administration for use in pediatric populations, according to a new report from the American ...

Over the past year, the application of generative AI (genAI) in the Medical Instruments industry has moved from experimental to operational, transforming diagnostics, patient monitoring and ...

FDA loses two key leaders as Jessica Paulsen departs Digital Health Center and David McMullen joins Neuralink amid staffing ...

The "Contract Manufacturing of Medical Devices: Global Markets" report has been added to ResearchAndMarkets.com's offering.The global market for contract manufacturing of medical devices is estimated ...

The FDA formally kicked off its quinquennial process to reauthorize the federal user fee legislation that helps fund its medical device reviews by hosting discussions with the medtech industry and ...

ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. The Food and Drug Administration rarely uses its authority to ...