Judge Orders Sanofi to Turn Over Regulatory Documents in FCA Suit

Attorneys for the whistleblower argued that the documents in question are not protected by attorney-client privilege. Read More

483sOnline.com Your Personal Pre-inspection Toolkit

Rest easy knowing you can identify exactly what FDA investigators are focusing on – before they show up! Read More

FDA Proposes to Drop Second Appeals for Medical Product Classifications

The second appeal process has been “confusing to sponsors and inefficient for sponsors and agency staff,” the FDA said. Read More

International Devices and Diagnostics Monitor

Stay ahead of the competition with this resource that brings you a global picture of the medical device regulations that affect your business. Read More
The Solutions Center