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The FDA requires retention of investigational drug study records for:

  1. 5 years following the study completion

  2. At least 2 years after the investigational drug's approval by the FDA

  3. 10 years from the study start date

  4. Indefinitely, as long as the drug is on the market

The correct answer is: At least 2 years after the investigational drug's approval by the FDA

The FDA requires retention of investigational drug study records for at least 2 years after the investigational drug's approval by the FDA. This is to ensure that the records are available for review and inspection during the drug approval process. A 5 years following the study completion is incorrect because the records may be needed for longer than 5 years, especially if there are questions or concerns during the drug approval process. C: 10 years from the study start date is incorrect because the approval date may not coincide with the study start date. D: Indefinitely, as long as the drug is on the market is incorrect because the FDA requires a specific timeframe for record retention, and not an indefinite period.