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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.[ Price : $8.95]
FDA warns Indias Wilson Medicine Co. about CGMP violations in the production of finished drugs.[ 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 an opportunity for public comment on an information collection extension entitled Generic D...[ Price : $8.95]
CDER Office of Process and Facilities branch chief Ying Zhang outlines common issues and deficiencies cited during pre‐appro...