FDA’s requirements for clinical investigator d closure and the Open Payments requirements are at odds in many ways. This article explores those differences and what might be done to remedy the situation.
As healthcare costs continue to rise and available resources shrink there continues to be concern that financial interactions between healthcare professionals, including medical researchers and life sciences companies may unduly bias the professional’s independent judgment. Besides poor treatment decisions and higher overall health care costs, some argue that these interactions even undermine the regulatory application and approval process.
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Read Full Article in the September 2016 Issue of Life Science Compliance Update