3 ms·
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:
by mbauman 4y ago
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/CFRSearch.cfm?fr=314.80 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.