The Regulatory Services Core (RSC) provides oversight and coordination for all functions within the GNL required to support and conduct studies in accordance with the FDA's G LP regulations, as outlined in the Code of Federal Regulations, Title 21, Part 58 (21 CFR Part 58), and associated guidance documents. It is anticipated that these studies will involve development and validation of animal models for biodefense and emerging infectious disease agents, as well as pre-clinical testing of candidate vaccines and therapeutics, including testing under the FDA Animal Rule (21 CFR Parts 314 and 601) and/or generation of safety and efficacy data that might support licensure under an Emergency Use Authorization. The RSC will be responsible for coordination of efforts amongst individual investigators, other core laboratories (both within and outside the GNL), GNL management, UTMB's Institutional GLP program office, the NIH, the FDA and industry, to ensure the quality and integrity of data generated in these studies.
The activities of the RCC are essential to the mission of the GNL. The development of vaccines, therapeutics and diagnostic assays for use against biodefense-related infectious disease agents will require that these products be tested and evaluated under high biocontainment conditions in a manner compliant with the GLP regulations, particularly in instances where product approval by the FDA will occur via the
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