Federal Circuit Junks Boston Scientific Win in Stent Patent Fight

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-130x160

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.

Events

View All

May 22

The FDA in a Post-Gottlieb World: Gottlieb’s Accomplishments, New Policies — and a Look Ahead

May 29

Four Hot Topics in FDA Regulation & Compliance: Opioids, Biosimilars, Right-to-Try and…

May 30

Part 806 Reports: When to Submit? — Is It a Device Recall … or Product Enhancement?

May 30

Statistical Concepts of Process Validation

Jun 6

5 Design Change Considerations to Stay Compliant

Jun 10

EU-Medical Device Regulation Compliance Workshops

Editor's Picks

View all

Flat Medical’s Epidural Protector Cleared by FDA

The syringe alerts anesthesiologists to the moment it has arrived at the epidural space, avoiding the risk of accidental puncture.

Gore Gains FDA Approval for Stent Graft

The graft features a staged deployment process for increased accuracy during placement.