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Are researchers facing FDA crackdown on trial fraud?
The RPM Report is predicting--or perhaps just speculating--that the FDA is gearing up for a significant crackdown on drug investigators. Clinical investigators found to have committed fraud or violated practices can be disqualified from conducting trials.
The CDER's Office of Compliance director Deborah Autor told a recent conference that the Division of Scientific Investigations is "becoming more activist. I think that they are really gaining momentum in what they do from an enforcement context." Currently, she adds, the process for taking actions against investigators are slow moving and "Byzantine." Of course, many drug companies would use the same description of the FDA in general.
- read the story in the RPM Report
ALSO: The parallel review of drugs by CMS and the FDA is back--and raising concerns for developers. Article
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