Medical device maker ev3 Inc. received U.S. Food and Drug Administration clearance to market a new stent product.
St. Paul Business Journal (http://www.bizjournals.com/twincities/stories/2006/03/20/daily2.html)
Simplifying Global Compliance
Recommended Products
EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements
The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition
Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.
Editor's Picks
Texas Device Manufacturer, Sterilizer Draws FDA Warning Letter
The process challenge packs used for sterilization did not represent the facility’s routinely sterilized components, the agency said.
SK Life Science’s XCOPRI Approved for New Treatment for Adults With Partial-Onset Seizures
The company is expected to make the drug available in the second quarter of 2020.
