FDA Approves Amgen’s Evenity for Postmenopausal Women

The agency required a boxed warning telling patients that the drug may increase the risk of heart attack, stroke and cardiovascular death.  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 Shuts Down Sales of Surgical Mesh Products

Two manufacturers selling three surgical mesh products did not conduct a sufficient assessment of their devices’ long-term safety, the agency 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