News & Events
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November 22, 2017
What Evidence Do We Need for Biomarker Qualification?
Leptak C, Menetski JP, Wagner JA, Aubrecht J, Brady L, Brumfield M, Chin WW, Hoffmann S, Kelloff G, Lavezzari G, Ranganathan R, Sauer JM, Sistare FD, Zabka T, Wholley D. What Evidence Do We Need for Biomarker Qualification? Science Translational Medicine. 2017 Nov 22;9(417).
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November 16, 2017
FDA CDER Regulatory Science: The Importance of Partnership and Consortia
Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research within the United States Food and Drug Administration, explains how the FDA works with academic researchers, pharmaceutical companies, and other healthcare organizations to help identify scientific gaps in drug development. Find out how these partnerships and consortia improve FDA’s ability to review drugs.... - November 15, 2017
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November 6, 2017 - November 7, 2017
Proceedings from Huntington’s Disease Regulatory Science Consortium (HD-RSC) Kick-Off Meeting, Nov. 6-7, 2017
On November 6 and 7, 2017, in Silver Spring, MD, Critical Path Institute and CHDI Foundation welcomed participants from the pharmaceutical industry, academia, regulatory agencies, and advocacy groups to a kick-off meeting for the Huntington’s Disease Regulatory Science Consortium (HD-RSC). The meeting objectives were to solicit input from stakeholders on HD-RSC plans and deliverables, and... -
November 4, 2017
Evaluating the Conceptual Equivalence Between Paper and Three Electronic Data Collection Modes of the EQ-5D-5L Health Status Instrument
Crescioni M, Flood E, Lundy JJ, Coons SJ, Byrom B, Eremenco S. Evaluating the Conceptual Equivalence Between Paper and Three Electronic Data Collection Modes of the EQ-5D-5L Health Status Instrument. International Society for Pharmacoeconomics and Outcomes Research 20th Annual European Congress; 2017 Nov 4; Glasgow, Scotland.
