Coverage

Imperatives for United States Clinical Research Leadership and Coordination
The United States spends nearly 18 percent of its gross domestic product on health care, yet health outcomes continue to lag behind those of peer nations, even as US leadership in life sciences faces growing global competition. This report argues that…
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FDA Launches Rare Disease Framework Initiative to Modernize Small-Cohort Trial Design
To begin shaping the detailed regulations, revised guidances, and internal reviewer training modules, the FDA will convene a major public stakeholder summit on October 28 at its White Oak headquarters in Silver Spring, Maryland, facilitated by the…
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Special Seminar: An Interactive Session Offering Expert Insight on Engaging Potential Research Support
As an appointee to the board of the FDA’s Reagan-Udall Foundation, Ed joins a high-profile list of life sciences leaders including former FDA Commissioners, global biotech executives and CMS health policy administrators.
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FDA Awards $2.51 Million Contract That Includes Cannabis Public Health Messaging Campaign
The contract was awarded last week to the Reagan-Udall Foundation for the FDA for $2,510,454. The Reagan-Udall Foundation is also expected to produce a white paper and communications report summarizing the stakeholder process and testing results and…
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Longevity Drugs Need Endpoints That Predict Clinical Benefit
Candidate measures that could be linked to the biology of aging were discussed at a May 2026 public meeting convened by the Reagan-Udall Foundation for the FDA with the Advanced Research Projects Agency for Health.
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BRC Therapeutics Joins FDA And EMA Regulators At Workshop Advancing The Future Of Botanical Drug Development
The workshop also builds on an invitation-only botanical drug development roundtable that the FDA's Center for Drug Evaluation and Research convened with the Reagan-Udall Foundation for the FDA.
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The FDA Promises To Streamline the Dauntingly Complex Rules for Approving Nicotine Products
A 2022 analysis by the Reagan-Udall Foundation noted that the FDA had "struggled to function as a regulator in part due to some of its policy choices," including the "scope of the product review regulations," which "have been difficult for both…
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BioFuture 2026 Convenes Industry Leaders in New York City to Explore the Trends Reshaping Biopharma and Healthcare
Next Wave of Innovation: Navigating Policy and Regulatory Headwinds, featuring Cartier Esham, Esham Strategies; Jennifer Hawks Bland, NewYorkBIO; William Soliman, ACMA; Blake Wilson, Hogan Lovells Cadwalader; and Susan Winckler, Reagan-Udall Foundation…
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FDA Plans Cannabis Public Health Messaging Initiative With Consumer and Healthcare Provider Testing
FDA intends to award a sole-source contract to the Reagan-Udall Foundation for the FDA to carry out 16 regulatory science and public health projects, including a dedicated project titled “Cannabis Public Health Message Testing.”
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Spruce Biosciences at H.C. Wainwright: BLA Path Comes into Focus
The regulatory picture changed in February 2024, when the FDA held a Reagan-Udall Foundation forum on neuronopathic mucopolysaccharidoses.
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