Guidance for industry on providing regulatory information ...
This document details the requirements for the submission of non-eCTD electronic submissions (NeeS). ... Clinical m1-4-3-clinical 1.5 Specific requirements for different types of applications m1-5-specific-requirements 1.5.1 Literature based submission documents m1-5-1-literature-based 1.5.2 Orphan drug designation m1-5-2-orphan 1.5.3 ... ................
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