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A Paragon Health Institute white paper suggests an approach to regulating healthcare artificial intelligence that it says builds o...[ Price : $8.95]
Based on FDA feedback, NeuroSense Therapeutics says it will begin a Phase 3 study of PrimeC (ciprofloxacin and celecoxib) for trea...[ Price : $8.95]
CDRH issues an early alert on a Fresenius Kabi high-risk Ivenix large-volume pump issue, the Centers first alert under a new commu...[ Price : $8.95]
Four stakeholders suggest changes to a CDRH/CBER draft guidance on incorporating patient preference information over the total pro...[ Price : $8.95]
scPharmaceuticals says a planned supplemental NDA submission of an autoinjector as an alternative to the current on-body infusor u...[ Price : $8.95]
Federal Register notice: FDA announces the renewal of its Science Board for an additional two years.[ Price : $8.95]
Troutman Pepper attorneys explain the potential benefits in FDAs new Emerging Drug Safety Technology Program.