CDRH says it is implementing a reorganization centered on a new Office of Product Evaluation and Quality that has been in a one-year pilot program.
The House Judiciary Committee unanimously passes four bills to address high prescription drug prices in different ways.
CDRH materials engineer Scott McNamee reviews a new finalized guidance on using animal tissues in medical devices.
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 ...