Marissa Hill Daley
Subscribe to Marissa Hill Daley's PostsMarissa Hill Daley focuses her practice on healthcare and US Food & Drug Administration (FDA) matters, including advising clients on regulatory compliance, government and internal investigations, and FDA marketing requirements. Marissa also defends clients against whistleblower qui tam suits that involve the False Claims Act and the Anti-Kickback Statute. Read Marissa Hill Daley's full bio.
FDA Pushes to Diversify Clinical Studies, Releases Draft Industry Guidance
By James Ravitz, Jennifer S. Geetter, Jiayan Chen, Paul Gadiock, Jeff Weinstein, Marissa Hill Daley, Nathan Gray and Karis Jackson on Aug 20, 2024
Posted In Employee Benefits, Health and Welfare Plans
On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. The draft guidance provides valuable information about what steps the FDA will expect sponsors to take to promote adequate representation across demographic characteristics in...
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FDA Establishes CDER Center for Drug Innovation (C3TI)
By James Ravitz, Paul Gadiock, Jiayan Chen, Marissa Hill Daley, Nathan Gray and Karis Jackson on May 29, 2024
Posted In Employee Benefits, Health and Welfare Plans
On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support hub for innovative approaches to clinical trials designed to improve the quality and efficiency of drug development and regulatory...
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Imported Drugs: (Possibly) Coming Soon to a State Near You
By James Ravitz, Paul Gadiock, Marissa Hill Daley, Nathan Gray and Karis Jackson on May 16, 2024
Posted In Employee Benefits, Health and Welfare Plans
In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from the US Food and Drug Administration (FDA) for importation programs under Section 804 of the Federal Food, Drug, and Cosmetic Act (FDCA) to import...
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