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Posts Tagged ‘Protocol’

Don’t Let Your Investigators Ruin Your Study By Doing This

I enjoy reading FDA Warning Letters. They’re insightful and often entertaining. Sometimes, though, they’re kind of unbelievable. And, sometimes, they’re downright nauseating. Take, for example, this letter issued on February 19, 2016 to a principal investigator (PI) based in New York. FDA inspectors found him to be in violation of 21 CFR Part 312.62(b), related […]