Report
Note: Workshop Summaries contain the opinion of the presenters, but do NOT reflect the conclusions of the IOM. Learn more about the differences between Workshop Summaries and Consensus Reports.
The U.S. Food and Drug Administration (FDA) carries out one of the most critical consumer protection functions of the federal government: ensuring the safety of prescription drugs taken by millions of Americans. Since 1992, however, federal funding for the agency has diminished, and recent highly publicized events such as the recall of Vioxx have damaged public confidence in the agency. The IOM report released in September 2006, The Future of Drug Safety: Promoting and Protecting the Health of the Public, provided an independent assessment of the current U.S. drug safety system and included 25 recommendations for improving the system for drug safety review.
Like many government agencies, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments. To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM’s Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. The symposium addressed the financial implications of many of the IOM’s recommendations, including strengthening the scientific base of the agency, integrating pre- and postmarket review, enhancing postmarket safety monitoring, conducting confirmatory drug safety and efficacy studies, improving clinical trial registration, and bolstering FDA’s regulatory and enforcement authority. The proceedings of the symposium are summarized in Challenges for the FDA: The Future of Drug Safety, Workshop Summary.
Other Reports by this Activity
Displaying: 3 of 14 Reports
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Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development - Workshop Summary
The development and application of regulatory science – which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products – calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.
Released: December 21, 2011
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Public Engagement and Clinical Trials: New Models and Disruptive Technologies - Workshop Summary
Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to find out whether they are effective and to assess any harm that may arise from treatment. There is growing recognition among many stakeholders that the U.S. clinical trials enterprise is unable to keep pace with the national demand for research results. The IOM, along with the Mount Sinai School of Medicine, held a workshop June 27-28, 2011, to engage stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials.
Released: October 14, 2011
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Advancing Regulatory Science for Medical Countermeasure Development - Workshop Summary
Whether or not the United States has safe and effective medical countermeasures—such as vaccines, drugs, and diagnostic tools—available for use during a disaster can mean the difference between life and death for many Americans. The Food and Drug Administration (FDA) and the scientific community at large could benefit from improved scientific tools and analytic techniques to undertake the complex scientific evaluation and decision making needed to make essential medical countermeasures available. At the request of FDA, the IOM held a workshop to examine methods to improve the development, evaluation, approval, and regulation of medical countermeasures.
Released: June 15, 2011
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