Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies; Public Meeting
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled "Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies." This public meeting will satisfy the mandate of the Food and Drug Omnibus Reform Act of 2022 (FDORA) to convene a public meeting on clinical study flexibilities initiated in response to the COVID-19 pandemic. The public meeting will be convened and supported by a cooperative agreement between FDA and the Clinical Trials Transformation Initiative (CTTI) to bring the clinical research community together to discuss a variety of topics related to mitigating disruptions of clinical studies of medical products during disasters and public health emergencies (PHEs). The meeting format will include presentations and panel discussions.
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