FDA clears an eNeura 510(k) for its Spring TMS, indicated for the acute and prophylactic treatment of migraine headache.
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...
FDA releases an FDA-483 with 12 inspection observations from Koreas Celltrion drug manufacturing facility.
FDA recommends an increased dosage of GamaSTAN S/D when used for hepatitis A prophylaxis.
FDA publishes a guidance to help manufacturers of certain specified human cells, tissues, and cellular and tissue-based products report deviations.
Federal Register notice: FDA announces a 10/3 public meeting entitled Development of a List of Pre-DSHEA Dietary Ingredients.