Building a National Framework for the Establishment of Regulatory Science for Drug Development - Workshop Summary


Note: Workshop Summaries contain the opinion of the presenters, but do NOT reflect the conclusions of the Health and Medicine Division or the Academies. Learn more about the differences between Workshop Summaries and Consensus Reports.

The Food and Drug Administration (FDA) is tasked with regulating drugs to ensure that Americans have access to medicines that are both safe and effective. FDA’s science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence and keep pace with innovation, so that research is translated into treatments for patients. FDA Commissioner Margaret Hamburg describes "regulatory science" as "the critical bridge between basic scientific research discoveries and new marketed medical products," including drugs. Regulatory science, therefore, touches upon a range of disciplines--not only biomedical science, but also law, public health, and statistics. In 2010, FDA established a Regulatory Science Initiative that will work to develop new scientific tools, technologies, and approaches to strengthen the scientific decision making of the agency and accelerate the development of quality medical products.

The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it. The workshop provided an opportunity for stakeholders to clarify and explore the concept of regulatory science, examine how it can be used to improve regulatory decision making, consider its funding needs, and contemplate alternative mechanisms and institutional frameworks for its development and application. This document summarizes the workshop.

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