FDA Clinical Investigator Site Inspections: The Sponsor's Role

@article{Huddleston1999FDACI,
  title={FDA Clinical Investigator Site Inspections: The Sponsor's Role},
  author={Richard D. Huddleston},
  journal={Therapeutic Innovation & Regulatory Science},
  year={1999},
  volume={33},
  pages={965 - 968}
}
  • Richard D. Huddleston
  • Published 1999
  • Medicine
  • Therapeutic Innovation & Regulatory Science
  • Once a New Drug Application (NDA) is submitted to the Food and Drug Administration (FDA) for review and potential approval, it is likely that at least some of the clinical trial investigators will be inspected by the FDA. Study issues of noncompliance and/or data integrity can result in costly approval delays. This paper will describe the role of the sponsor in dealing with an FDA clinical trial site inspection including selection of clinical trial sites, timing of sponsor inspections, site… CONTINUE READING

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