Prospective assignment of participants to one or more interventions (which may include placebo or other control); Evaluation of the effects of the interventions on biomedical or behavioral ...

Chastened after a decisively negative review from outside advisers, the Food and Drug Administration convened a series of internal meetings in March and April where top officials hammered out a plan ...

The draft guidance issued Thursday, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, covers a wide range of cybersecurity device design, labeling ...

In the ever-changing regulatory landscape that alcohol manufacturers must navigate, the regulations imposed by the U.S. Food and Drug Administration (FDA) are often overlooked. But breweries, ...