FDA commissioner Scott Gottlieb says the agency plans to revamp its early pre-clinical involvement with medical product developers as part of a new St...
FDA clears an eNeura 510(k) for its Spring TMS, indicated for the acute and prophylactic treatment of migraine headache.
FDA recommends patients not take Kayexalate and other oral medicines at the same time to prevent reducing the effectiveness of the other medicines.
PharMEDium Services recalls all unexpired lots of oxytocin compounded with lactated ringers and all unexpired lots of oxytocin compounded with lactate...
FDA clears an OmniLife Science 510(k) for its proprietary robotic tissue balancing device for use with the companys OmniBotics robotic-assisted total ...
Attorney Jennifer Thomas says a Boston Scientific whistleblower given a green light to refile a suit may have difficulty demonstrating False Claims Ac...
The Justice Department says Novo Nordisk is paying more than $58 million to resolve False Claims Act and Federal Food, Drug, and Cosmetic Act violatio...
Federal Register notice: FDA makes available a guidance on Design Considerations and Pre-market Submission Recommendations for Interoperable Medical D...