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  3. Regulatory Support

Regulatory Support

The Office of Regulatory Support (ORS) offers services to support investigators with the navigation of and compliance with a range of governing requirements. In addition to general assistance with requirements as they arise, expertise is provided to support specific FDA-regulated processes, including research involving experimental drugs and devices, as well as preclinical laboratory studies.

  • ClinicalTrials.gov Guidance for Required Reporting
  • Regulatory Science - Research and Education
  • Preclinical Studies Guidance for FDA GLP
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