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NIH Program to Study Patients with Mystery Diseases

For thousands of frustrated patients with diseases that cannot be explained or diagnosed—even by leading specialists in their field—enrollment in clinical trials has not been an option. Without a definitive diagnosis, they are ineligible to participate. Now, through a pioneering program launched by the National Institutes of Health (NIH), there may be hope. The new trans-NIH initiative, called the Undiagnosed Disease Program, will concentrate its research efforts on patients who suffer from unknown, thus unstudied, illnesses.

CDER’s Woodcock Details Expanded Authority, Sentinel Concept at Post-Approval Summit

Opening the Post-Approval Summit at Harvard, keynote speaker Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), outlined her agency’s expanded authorities in the area of post-approval research oversight brought about by the passage of the FDA Amendments Act (FDAAA) into law at the end of March.

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Company Profile: An interview with Steve Toon, Ph.D., executive director, Simcyp

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