Module 12 2019

US Requirements for Clinical Data

Per21CFR314.50:

(1) Case report tabulations. The NDA is required to contain tabulations of the data from each adequate and well- controlled study under 314.126 (Phase 2 and Phase 3 studies as described in 312.21 (b) and (c) of this chapter), tabulations of the data from the earliest clinical pharmacology studies (Phase 1 studies as described in 312.21(a) of this chapter), and tabulations of the safety data from other clinical studies.

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