Tuesday, October 06, 2020 8:51:11 AM
The IND application sponsor is expected to address the cited deficiencies in writing and submit a complete response to the issue(s) identified in the clinical hold letter in a separate submission. Once the complete response to all of the clinical hold deficiencies has been received, FDA will review the submission within 30 calendar days and determine whether the applicant’s response to clinical hold satisfactorily addresses the issues.
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