Sponsor Notified of Deficiencies

If other deficiencies are found in an IND that the review division determines are not serious enough to justify delaying clinical studies, the division may either telephone or forward a deficiency letter to the sponsor. In either case, the division informs the sponsor that it may proceed with the planned clinical trials, but that additional information is necessary to complete or correct the IND file, or that there are issues that need to be addressed prior to a marketing application (NDA) submission.