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Quality Takes Time, FDA’s CDER Reminds Drug Makers

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Got Safe Beef?

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The next time you want a cheeseburger, you might consider hopping a plane and flying to Germany. Or France. Or New Zealand. Basically, anywhere but the United States of America.

FDA’s Local Offices Flex Regulatory Muscle

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Are You Ready for 21st-Century eMDR Submissions?

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Common Cause: IMDRF and the Medical Device Single Audit Pilot Program

  • Read more about Common Cause: IMDRF and the Medical Device Single Audit Pilot Program
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<em>Kaizen</em> Blitz for Ebola Safety Solutions

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Sub-Zero Solutions for Pharmaceutical Standards

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FDA Proposals Take a Fresh Look at Some Stale Food Issues

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It’s Time to Get IEC 62304 Before It Gets You

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ISO 13485 Certification for Temporary Labor and Staffing Services

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Medical device manufacturers are facing mounting pressure to better manage the quality of their supply chain. One approach they’ve taken to improve risk management and increase efficiency is to partner with suppliers who are ISO 13485 certified.

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