RSS
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 Hands Cleveland Diagnostics’ Prostate Cancer Test Breakthrough Status
“We believe that IsoPSA has the potential to fill a major void in this space,” the company said.
Buttigieg Drug Pricing Plan Targets ‘Worst Offender’ Drugmakers
Buttigieg’s proposal would take advantage of provisions of the Bayh-Doyle Act to “acquire” companies’ intellectual property when price negotiations fail.
Regulatory Affairs
