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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.

Events

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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.

MEMORY TO START TRIAL OF ALZHEIMER'S DRUG

KEYWORDS Drug Pipeline Alert
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Memory Pharmaceuticals has announced that it will begin a Phase IIa clinical trial of MEM 3454 for Alzheimer's disease.

MEM 3454 was safe and well-tolerated in Phase I trials, including treatment with 450 mg dosages during the single-ascending-dose portion of the trial program. The drug was also safe and generally well-tolerated with 150 mg dosages in the multiple-ascending-dose portion of the program.