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Two stakeholders raise questions about proposed Office of Prescription Drug Promotion research into quantitative claims in direct-...[ Price : $8.95]
FDA reiterates the indication and instructions for use of the NuVasive Specialized Orthopedics Precice Intramedullary Limb Lengthe...[ Price : $8.95]
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 inc...[ Price : $8.95]
FDA clears an Overjet 510(k) to expand the use of its artificial intelligence technology for predicting tooth decay in younger pat...[ Price : $8.95]
FDA approves a Pfizer and OPKO Health BLA for Ngenla (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for t...[ Price : $8.95]
FDA sends Eton Pharmaceuticals a second complete response letter on its NDA for dehydrated alcohol injection for treating methanol...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Prohibition on Wholesaling Under Section 503B of the Federa...[ Price : $8.95]
FDA releases the form FDA-483 with four observations issued following an inspection at the Prisma Health outsourcing facility in S...