PhRMA says it appreciates the FDA approach in a draft guidance on investigator responsibility for safety reporting for investigational drugs and devic...
The Justice Department says a self-employed medical device sales rep has agreed to pay $100,000 to resolve allegations he assisted in causing the subm...
Federal Register notice: FDA classifies the conditioning tool for eating disorders into medical device Class 2 (special controls).
Federal Register notice: FDA classifies the esophageal tissue characterization system into Class 2 (special controls).
A CDER executive tells a hemp industry conference that FDA still needs more information before it can address the use of CBD in food and dietary suppl...
The Justice Department says two former Immunomedics officials have been arrested on charges of insider trading.
FDA clears a CoreLink 510(k) for its CentraFix Midline Spinal Fixation System.
FDA clears a Sound Life Sciences 510(k) for its sonar software for consumer smart devices for measuring breathing.