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
Lucid Diagnostics Earns 510(K) Clearance for Esophageal Cell Collector
The device is an alternative to sponge-on-a-string devices used to gather esophageal cells.
Pfizer to Expand Oncology Reach With $11.4 Billion Array BioPharma Merger
The company expects to complete the acquisition later this year, pending regulatory approval.
Regulatory Affairs
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