Off-Label Dissemination May Be Clarified – Indirectly – By FDAAA Regs
Executive Summary
Issues surrounding off-label dissemination may be clarified through regulations required by the FDA Amendments Act of 2007
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Off-Label Dissemination Keeps FDA Stuck Between Prosecutors And Firms
As industry weighs the potential impact of FDA's guidance on good reprint practices, stakeholders are suggesting alternate policy approaches that could give companies sufficient clarity on how to conduct off-label dissemination
Off-Label Dissemination Keeps FDA Stuck Between Prosecutors And Firms
As industry weighs the potential impact of FDA's guidance on good reprint practices, stakeholders are suggesting alternate policy approaches that could give companies sufficient clarity on how to conduct off-label dissemination
FDA’s Off-Label Dissemination Guidance Opens “Loophole” – Rep. Waxman
Rep. Henry Waxman, D-Calif., made another move in his fight against off-label drug promotion Nov. 30, releasing an internal FDA 1draft guidance on "good reprint practices" and sending a strongly worded 2letter to Commissioner Andrew von Eschenbach