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
Delegates Flag Concerns Over EU’s Device, IVD Regulations
More than 80 percent of IVDs will need to be assessed and certified by a notified body before being placed on the EU market.
ALK Allergy Drug Nothing to Sneeze At, European Regulators Say
The approval comes after ALK handed up positive results from a Phase 3 trial.
