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 Clears Lumendi’s Single-Use Endoscopic Electrosurgical Knife
The product is able to administer a submucosal injection as tissue dissection is taking place in the digestive tract to create and maintain a fluid cushion.
FDA Collaboration Pulls RWE in Clinical Oncology Trials
Syapse’s oncology researchers will participate in the effort.
Regulatory Affairs
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