CDRH Forecasts New Technological Trends, More Inter-Center Collaboration
This article was originally published in The Gray Sheet
FDA's Office of Science and Engineering Laboratories has revamped its research priorities and retrained staff to focus on improving both premarket and postmarket programs and regulatory science across CDRH
You may also be interested in...
FDA is updating the label for the anti-clotting drug warfarin to inform physicians and patients about the usefulness of genetic testing before beginning therapy, but the agency will wait for data from ongoing studies of the tests before adding stronger recommendations for the tests
The Critical Path Institute's new Director of Medical Devices and Imaging, Ellen Feigal, MD, is working with device firms to identify key roadblocks to product development and clear the way to regulatory approval for those products
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.