Simplifying Global Compliance
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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
Restoration Robotics Gains European Approval for Hair Restoration System
The system automates significant parts of hair transplantation procedures.
Amgen Wins New Jersey Court Ruling for Two Enbrel Patents
The federal court was not persuaded by Sandoz’s arguments that the patents were insufficiently written and based on prior art.
Windtree Earns Fast Track Designation for Heart Failure Drug
The drug has “a well characterized safety profile,” Windtree says. Read More
483sOnline.com Your Personal Pre-inspection Toolkit
Rest easy knowing you can identify exactly what FDA investigators are focusing on – before they show up! Read More
FDA Hands Breakthrough Designation to Ascyrus’ Dissection Stent
The stent reduces the size of the aorta. Read More
Clinical Trial Risk and Performance Management Summit
Discover the secrets to implementing a successful metrics program. Read More
Surviving the New FDA Inspection Plan: A Drugmaker’s Guide to Working with the Agency
Surviving the New FDA Inspection Plan: A Drugmaker’s Guide to Working with the Agency explains the agency’s integrated approach and how you can make the most of the FDA’s quality priorities and inspection procedures.
Regulating Digital Health Tools: Understanding the FDA’s New Guidances
Regulating Digital Health Tools — based on a presentation by noted regulatory expert Bradley Merrill Thompson — combs through the guidances and sets out the rules devicemakers must follow.
The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium
This new edition of The 21st Century Take on Observational Studies presents new information on the encouraging results those pioneers have found. New to this edition are the results of a groundbreaking study from Tufts University’s Center for the Study of Drug Development.
The Solutions Center
