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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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Sep 24

Drug Regulation in China: Updates, Key Issues and Common Challenges

Sep 25

The AI Revolution: What You Must Know About Medical Imaging Regulation

Sep 27

Using IT to Improve Data Integrity: Optimizing Your Compliance Joint IT/QA Programs

Sep 27

FDA and EU Inspections — The Mutual Recognition Agreement: What’s Next?

Oct 1

Advanced GMP Training: The Seven Essentials for Compliance

Oct 4

Transparency and the New Medical Device Reporting Rules: What to Do Now That ASR is Really Over

Editor's Picks

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FDA Seeks Input on Risk-Benefit Reviews for Weight Loss Devices

The FDA said it “continues to receive a high volume of pre-submissions from industry requesting feedback about the necessary data to support pivotal clinical studies and marketing applications for a wide variety of device designs intended for weight loss.”
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Costa Rican OTC Drugmaker Hit for Testing, Stability Program

The company said it would employ a third-party testing laboratory, but it didn’t provide a description of the test it would conduct.
FDAnews Device Daily Bulletin

TOPSPIN MEDICAL GETS FDA APPROVAL TO START CLINICAL TRIALS IN THE US AND COMPLETES THE DEVELOPMENT OF A PROTOTYPE OF ITS ADVANCED GENERATION INTRAVASCULAR MRI (IVMRI) CATHETER

July 10, 2006
KEYWORDS FDAnews Device Daily Bulletin
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TopSpin Medical announced it has received FDA approval to start conducting clinical trials in the US with its IntraVascular MRI (IVMRI) catheter, intended for the characterization of lipid-rich lesions in the coronary arteries. TopSpin IVMRI catheter technology enables MRI to be performed in the clinic for the first time with no external magnets. To date the company conducted clinical trials with its IVMRI catheter in more than 70 patients in Europe and Israel, and following the FDA approval TopSpin intends to extend the clinical trials to leading US clinical sites.

Genetic Engineering News (http://www.genengnews.com/news/bnitem.aspx?name=3171975)