Two Centers for Medicare and Medicaid Services officials describe the principles in a new coverage rule for innovative medical devices the agency is d...
Exela Pharma Sciences (Lenoir, NC) recalls 49 lots of sodium bicarbonate injection due to safety concerns.
FDA seeks public comments on a Statement of Work mandated by the recent drug user fee reauthorization to assess communication between the agency and s...
A Miami grand jury charges three defendants for their roles in an alleged scheme to fabricate and falsify clinical drug trial data submitted to FDA.
FDA publishes the International Council for Harmonization E19 guideline on selective safety data collection in some circumstances.
CDER asks an FDA hearing officer to direct Covis to provide additional information on items from its final briefing materials for an upcoming hearing ...
GlaxoSmithKline says its investigational adult respiratory syncytial virus vaccine candidate was highly effective in a Phase 3 trial, with a favorable...
FDA says Teva manufacturing delays have led to a shortage of Adderalls immediate-release formulation.
