CBER issues a revised guidance agenda for 2023 with 13 likely guidances in three categories.
Republican Sens. Scott, Vance, and Braun criticize FDAs decision to allow the importation of some Chinese-approved cancer drugs to help alleviate the ...
Two stakeholders raise questions about proposed Office of Prescription Drug Promotion research into quantitative claims in direct-to-consumer prescrip...
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.
