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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.
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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.

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Oct 21

FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers

Oct 23

14th Annual FDA Inspections Summit

Oct 29

Labeling for Prescription Drugs, Biologics and Combination Products: Complying with FDA’s...

Oct 30

EDC vs eSource: Is it Time to Move?

Oct 31

Develop World-Class SOPs that Minimize Human Error: Improve Your Productivity, Quality...

Nov 5

How to Address Medical Device Sample Size Issues: What Regulatory and Quality Professionals Absol...

Editor's Picks

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HHS to Report on Postmarket Surveillance in 2020

The report will analyze how the agency responds to safety concerns.
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California Inks Nation’s First Pay-for-Delay Law

The new law presumes that “these agreements are anti-competitive and delay the entry of the generic drug into the market place,” notes the state’s Attorney General Xavier Becerra.

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FDA Warns Euromi Over Complaint Handling

October 2, 2015
Belgium-based Euromi was slapped with a far-ranging FDA warning letter that chides the company for not properly handling complaints, including instances in which cannula tips from a liposuction system broke and became lodged in patients. Read More

Lawmakers Call on GAO to Investigate Power Morcellators

September 25, 2015
A bipartisan group of lawmakers is calling on the head of the U.S. Government Accountability Office to investigate why power morcellators remained on the market for more than two decades before being slapped with a black box warning last year. Read More

Liposuction Maker Hit With Warning Over Lax MDR

September 3, 2015
Belgium-based Euromi was slapped with a far-ranging FDA warning letter that chides the company for not properly handling complaints, including instances in which cannula tips from a liposuction system broke and became lodged in patients. Read More