FDA issues a complete response letter requesting further CMC and non-clinical studies for Heron Therapeutics HTX-011 investigational pain management d...
FDA clears a Surgical Information Sciences 510(k) to market new visualization capabilities for its deep brain stimulation software.
Federal Register notice: FDA seeks comments on an information collection extension for Mammography Quality Standards Act Requirements 21 CFR Part 900...
Federal Register notice: FDA announces an 8/8 public workshop entitled Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Imm...
FDA struggles to figure out how best to regulate hemp-based cannabidiol products after a provision in the 2018 Farm Bill clarified that hemp and hemp ...
FDA sends Nabriva Therapeutics a complete response letter on its NDA for Contepo (fosfomycin) injection for treating complicated urinary tract infecti...
K&L Gates attorneys review the changes coming 1/1/20 to the AdvaMed Code of Ethics on medical device company interactions with healthcare professional...
FDA warns Surgisil it is manufacturing unapproved medical devices and is making misleading statements about agency approval in its promotional materia...