No, as stated in the preamble to the final rule, submitting only
the Synopsis from Annex I of ICH E3 would not be adequate to meet the
requirement in 21 CFR 312.120(b)(3), because the Synopsis would not
provide sufficient detail about the study protocol or results.27 By contrast,
submitting an integrated, full CSR in accordance with ICH E3 would meet
this requirement, although alternative approaches are also acceptable.
Integrated, full CSRs are commonly submitted for clinical and human
pharmacology investigations that contribute to the evaluation of
effectiveness for the proposed indication or that otherwise support
information included in proposed labeling for the product.28 Sponsors and
applicants are reminded that, even if they submit such integrated, full
CSRs, they must also submit any additional information that is required by
21 CFR parts 312, 314, or 601.
