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Virtual Event
On November 2, 2022, the committee will discuss the Center for Drug Evaluation and Research (CDER) Quality Management Maturity (QMM) program. QMM is the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement. CDER has proposed the development of a rating system that will |
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Obese patients are a large segment of the U.S. population and should be included in medical countermeasure and drug development studies. There are presently no clear dosing guidelines for obese pediatric patients. The U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI)
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The FDA's Pulmonary-Allergy Drugs Advisory Committee Meeting will convene on 9 November 2022 to discuss the request for Emergency Use Authorization (EUA) for sabizabulin oral capsule, a tubulin polymerization inhibitor, submitted by Veru Inc., for the treatment of SARS-CoV-2 infection in moderate to severe COVID-19 infections at high risk of acute respiratory distress syndrome. Sabizabulin |
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The Biomedical Advanced Research and Development Authority (BARDA) 2022 Industry Day virtual event will be held 15-16 November 2022. BARDA, a component of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), invites you to participate in the annual conference to learn about U.S. Government |
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