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FDA’s Voluntary Compliance Improvement Program Receives Tepid Response

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It’s a growing trend in these United States: paying extra for conveniences such as bypassing the riffraff in airport security lines, or whizzing past mere mortal motorists on pristine, pay-for express lanes.

FDA Accepting Comments on ‘Medical Device Development Tools’

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The Beginning of the End for Fake ISO 13485 Certificates

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Many of us have heard horror stories about ISO certificates that were fakes, or of medical-device quality system audits being performed by persons who were not competent.

Former FDA Inspector’s Crystal Ball

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Improving Product Compliance With Quality Risk Management Data

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Medical Device Recalls Reach Five-Quarter High

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The Interoperability of Things

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Proposed Rules Will Strengthen Global Food Safety

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It’s a small world. Every day, there’s a good chance that some of the food you’re eating came from another country. Fifteen percent of the food we eat, including nearly 50 percent of the fresh fruit and 20 percent of vegetables, is imported each year.

When Conduct Becomes a Crime

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In an earlier article, I explained how the Food and Drug Administration’s (FDA)

Farm-to-Fork Traceability

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T

Pagination

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