Are Patient Advisers Contraindicated For Pharma Cos.?
Law360, New York (October 23, 2015, 6:08 PM EDT) -- Today, patients and patient organizations are front and center in the drug development process, not only as stakeholders, but as trusted advisers of drug developers. Yet, communications between developers and these groups can be fraught with risk, including jeopardizing the informed consent process, promoting investigational products prior to approval and promoting off-label uses of already approved products. In addition, public companies have the added worry of inadvertently disclosing nonpublic information about their product development plans or progress. There are a number of best practices clinical-stage drug developers can implement to help manage their legal and regulatory risk exposure while still forging collaborative partnerships with patients and patient organizations to help advance their drug development programs....
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