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by mbauman
1253 days ago
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It's not a random Pharma company mandate, it's an FDA one. I think it's in here: 21 CFR Part 314.80 Postmarketing reporting of adverse drug experiences. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFR... At its heart I get it — you don't want a company's employees to be burying reports of adverse events. But now the company is liable to ensure such things get reported. And thus they pass this liability onto their employees. |
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