A study of pediatric exclusivity trials finds that they have yielded useful information, but at a very high cost to consumers.
FDA clears an OrthoXel 510(k) for the Apex Tibial Nailing System, a fracture fixation device that can be surgically implanted from antegrade or retrog...
HHS cancels an FDA fetal tissue contract with Advanced Biosciences Research and opens an investigation into all fetal tissue research.
FDA clears a Synergy Biomedical 510(k) for the Biosphere Flex, a strip-format bone graft product made of porous, bioactive glass.
Researchers say pivotal clinical trials often are not the main reason for the high cost of drug development.
FDA warns Indias Wilson Medicine Co. about CGMP violations in the production of finished drugs.
FDA issues three guidances relating to insanitary conditions at drug compounding facilities and to repackaging or compounding of radiopharmaceuticals.
Federal Register notice: FDA announces an opportunity for public comment on an information collection extension entitled Generic Drug User Fee Cover S...