CDER director Janet Woodcock describes the Centers efforts to ensure drug safety and communicate its findings.
A Tufts Center for the Study of Drug Development analysis shows that U.S. dominance in worldwide drug research and development is being challenged by ...
FDA grants Novartis a breakthrough therapy designation for crizanlizumab (SEG101) for use in preventing vaso-occlusive crises in patients of all genot...
FDA classifies as Class 1 a Medtronic recall of its Synergy Cranial Software and Stealth Station S7 Cranial Software due to reports of incorrect infor...
Attorney Paulette Thomas says hospitals and other medical device vendors should pay attention to recent FDA guidelines on medical device cybersecurity...
A JAMA Special Communication says spending on medical marketing increased significantly between 1997 and 2016, but oversight of such marketing has rem...
CNN reports FDA employees saying they fear the government shutdown at their agency could cost lives, and commissioner Scott Gottlieb asks the network ...
The U.S. House of Representatives plans to vote this week to fund FDA under an Agriculture, Rural Development, Food and Drug Administration, and Relat...