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FDA releases the FDA-483 with 16 observations from an inspection at the Pharm D Solutions outsourcing facility.[ Price : $8.95]
Neurelis files an NDA for Valtoco (diazepam nasal spray) as a treatment for epilepsy in patients six years and older who experienc...[ Price : $8.95]
FDA clears a Renovis Surgical Technologies 510(k) to market the Tesera X Lateral Interbody Fusion System.[ Price : $8.95]
FDA issues three guidances relating to insanitary conditions at drug compounding facilities and to repackaging or compounding of r...[ Price : $8.95]
Federal Register notice: FDA announces the fee rate for using a tropical disease priority review voucher for fiscal year 2019 $2....[ Price : $8.95]
Federal Register notice: FDA issues a proposed order to reclassify the ultrasound cyclodestructive device, a postamendments Class ...[ Price : $8.95]
FDA clears a Synergy Biomedical 510(k) for the Biosphere Flex, a strip-format bone graft product made of porous, bioactive glass.[ Price : $8.95]
Researchers say pivotal clinical trials often are not the main reason for the high cost of drug development.