For an IND application in CTD format, Module 2.2 should include elements of the Introductory Statement as mandated by 21 CFR 312.23(a)(3)(i). All required elements outlined by the regulation should be incorporated, except for the ‘broad objectives and planned duration of the proposed clinical investigation(s),’ which should be included in Module 2.5 (Clinical Overview).

Read the full FDA guidance on Drug Substance Chemistry, Manufacturing, and Controls Information - Quality.