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I was a contractor working on an IS at the FDA in the early 2000's. Shortly before the VIOXX scandal (https://www.drugwatch.com/vioxx/). The number of cheats they were specifying to go around safeguards was scary. Fortunately, they fired the company I worked for and awarded the contract to the company employing the husband of one of the FDA managers. ISYN. A relief to leave.

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