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.