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US FDA cites investigator for promoting brow furrow jab before its approval

This article was originally published in Scrip

Executive Summary

The US FDA has stepped up its scrutiny of clinical trial investigators, not just drug makers, for pre-approval promotion that is violative. In a case that has drawn much attention, the agency criticised a researcher for having "promoted" an investigational product in US media outlets before FDA approval, in violation of agency regulations. The move has had the effect of "sending shudders" through key opinion leaders who often want to be quoted for publicity purposes, The New York Times said.



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