![]() ![]() FDA’s expanded access categories for unapproved medical devices are emergency use, compassionate (for single patient or intermediate-size population), and wide-spread treatment protocols or uses. VA adheres to FDA’s expanded access regulations, which includes the different categories of single patient, intermediate-size population, and wide-spread treatment protocols or uses for investigational drugs and biologics. However, R&D Committee prospective approval is required for any non emergency use of investigational medical products under FDA’s regulations. R&D Committee approval is not required for any emergency use of an investigational medical product (drug, biologic, or medical device) as described in FDA’s expanded access regulations in 21 CFR §56.104. Is R&D Committee approval required for all types of expanded access protocols or uses of investigational medical products, to include single patient, intermediate population, and treatment protocols? Federal-wide Research Performance Progress Report.Find VA-sponsored clinical trials near you.Alzheimer's Disease and Related Dementias.NIH Manuscript Submission for VA Investigators.ORD Program Guides, VHA Directives, Handbooks.VA Informatics and Computing Infrastructure (VINCI).VA SHIELD (Central Biospecimen and Data Repository).Gulf War Veterans' Illnesses Biorepository.VA Electronic Determination Aid (VAEDA).VA Innovation and Research Review System (VAIRRS).Office of Research Protections, Policy, and Education (ORPP&E).National Artificial Intelligence Institute (NAII).Diversity, Equity, and Inclusion Initiative (DEI). ![]() Centralized Interactive Phenomics Resource (CIPHER).Center for Data & Computational Science (C-DACS).Letters and Op-eds Concerning VA Research with Animals.National Academy of Sciences Assessment.Currently Approved VA Protocols for Research.Distinguished Medical Research Scientist.COVID-19 Observational Research Collaboratory. ![]()
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