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
Qiagen’s Syndromic Testing System Cleared by FDA
The company plans to release other diagnostics for infectious diseases, oncology and other areas.
Lilly Wins Approval for Liver Cancer Treatment
The approval comes after Lilly handed up results from the Phase III REACH-2 study which selected patients based on their AFP levels.
Submissions and Approvals
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