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Where foreign clinical trial data are not intended to serve as the sole basis for approval, the FDA will not accept the data as support for an application for marketing approval unless the trial is well-designed and well-conducted in accordance with GCP requirements and the FDA is able to validate the data from the trial through 67 an onsite inspection if deemed necessary
doi:10.1007/s10875-024-01696-8
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Step 7: Once the solution is completely clear with no visible particles or cloudiness, it is ready for use
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