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The FDA requires that sponsors and investigators maintain study records for a minimum of two years following the marketing approval of a drug. This requirement ensures that critical data pertaining to FDA Docket No. 89D-0140 remains accessible for review and inspection, which is essential for ongoing safety assessments. By adhering to this rule, sponsors demonstrate their commitment to regulatory compliance and public safety. Utilizing a reliable document management system can streamline this record-keeping process.
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