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.
All drugs undergo extensive safety and efficacy studies before being released; however, these studies can fail to identify potential adverse reactions that are rare or develop over a long period of use. As a result, serious adverse reactions may not be fully appreciated until a drug has been on the market for many years.
Although the FDA monitors post-market adverse drug events through its Adverse Event Reporting System and periodic reports submitted by the drugs' sponsors, concern has been raised about the effectiveness of the current post-market review system.
In November 2005, the Forum on Drug Discovery, Development, and Translation addressed this critical concern by convening a workshop and issuing a workshop summary exploring issues associated with the reporting of adverse drug events, and to consider how the roles of clinicians and patients in reporting such events can be enhanced.
Other Reports by this Activity
Displaying: 3 of 7 Reports
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Addressing the Threat of Drug-Resistant Tuberculosis: A Realistic Assessment of the Challenge. Workshop Summary
Tuberculosis is one of the leading causes of death in the world today, with 4,500 people dying from the disease every day. Many cases of TB can be cured by available antibiotics, but some TB is resistant to multiple drugs--a major and growing threat worldwide. The Institute of Medicine’s Forum on Drug Discovery, Development, and Translation hosted a workshop on November 5, 2008, to address the mounting concern of drug-resistant TB. The session brought together a wide range of international experts to discuss what is known and not known about this growing threat, and to explore possible solutions.
Released: August 26, 2009
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Accelerating the Development of Biomarkers for Drug Safety. Workshop Summary
Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM’s Forum on Drug Discovery, Development, and Translation held “Assessing and Accelerating Development of Biomarkers for Drug Safety,” a one-day workshop on the value of biomarkers in helping to determine drug safety during development.
Released: June 19, 2009
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Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies. Workshop Summary
The process for developing new drug and biologic products is extraordinarily expensive and time-consuming—many consider the traditional model to be unsustainable. Although large pharmaceutical companies may be able to invest in the development of blockbuster drugs because they can expect a large return on their investment, these same organizations, when developing drugs to treat rare and neglected diseases, are unable to rely on such returns. On June 23, 2008, the Institute of Medicine’s Forum on Drug Discovery, Development, and Translation held a public workshop, “Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies,” which sought to explore new and innovative strategies for developing drugs for rare and neglected diseases.
Released: February 19, 2009
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