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Four stakeholders suggest changes to a CDRH/CBER draft guidance on incorporating patient preference information over the total produce lifecycle.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