Expanded access to investigational drugs and devices has been available for decades through special pathways provided by the FDA. More recently, two federal actions have widened this access. 1. A federal law allowing for the "right to try" these same unapproved products has been enacted by US Lawmakers. 2. The previous rules governing expanded access have been modified to streamline the process to expedite such access. How do they differ? How should regulatory and research professional advise and/or assist patients faced with these choices? This session will provide a current and complete description of the two pathways, their advantages and challenges.Click here to purchase contact hour.
With more than 20,000 members, the Association of Clinical Research Professionals (ACRP) is the only non-profit solely dedicated to representing, supporting, and advocating for clinical research professionals. ACRP supports individuals and life science organizations globally by providing community, education, and credentialing programs. Founded in 1976, ACRP is a registered 501(c)(3) charitable organization whose mission is to promote excellence in clinical research and whose vision is that clinical research is performed ethically, responsibly, and professionally everywhere in the world.
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