site inspection
- Guideline or reference source
- FDA www.fda.gov
- Definition
- A division's decision to file an NDA begins the review process and, when needed, initiates a request for a preapproval inspection of the sponsor's manufacturing facilities and clinical trial sites. During such inspections, FDA investigators audit manufacturing-related statements and commitments made in the NDA against the sponsor's manufacturing practices.
- Related Term
- trial site
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