PhRMA asks FDA to give stakeholders significant lead time before implementing a new National Drug Code format.
FDA commissioner Scott Gottlieb unveils agency plans to create a new Office of Drug Evaluation Science to modernize the drug review process.
FDA denies a petition asking it to ban electroconvulsive therapy devices.
FDA announces plans to implement a software precertification pilot program initially under the de novo medical device pathway.
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...