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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
FDA Approves CVRx’s Advanced Heart Failure Treatment
The Barostim Neo was one of the first therapies to receive the FDA's Breakthrough Device designation.
FDA Approves New Treatment for Rare Bone Marrow Disorder
More than one third of patients who took the drug experienced a significant therapeutic effect and a decrease in symptoms.
Regulatory Affairs
