FDA clears a Cresilon 510(k) for Cresilon Hemostatic Gel to rapidly control bleeding without the need for manual pressure.
FDA publishes a draft guidance with recommendations on information to go in regulatory submissions for patient-matched guides to orthopedic implants.
FDA and National Cancer Institute researchers document an increase in oncology drug approvals since 2000 that they expect to continue into the future.
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...
