FDA reiterates the indication and instructions for use of the NuVasive Specialized Orthopedics Precice Intramedullary Limb Lengthening system.
FDA clears a Candela 510(k) to expand the labeled indication of its Vbeam Pulsed Dye Laser for use of the 595 nm wavelength to include treating pediat...
FDA clears an Overjet 510(k) to expand the use of its artificial intelligence technology for predicting tooth decay in younger patients.
FDA approves a Pfizer and OPKO Health BLA for Ngenla (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treating pediatric pa...
FDA sends Eton Pharmaceuticals a second complete response letter on its NDA for dehydrated alcohol injection for treating methanol poisoning.
Federal Register notice: FDA makes available a draft guidance entitled Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Co...
FDA releases the form FDA-483 with four observations issued following an inspection at the Prisma Health outsourcing facility in Simpsonville, SC.
Federal Register notice: FDA makes available a final guidance entitled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DT...
