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Module 2summarynda● High priority

2.5 — Clinical Overview

Clinical overview: benefit-risk analysis based on all clinical data (~30 pages for NDA)

Requirements by Phase

Phase 1
N/A
Phase 2
N/A
Phase 3
N/A
NDA
required

Clinical overview: benefit-risk analysis based on all clinical data (~30 pages for NDA)

Requirements by Phase

NDA: required

Content Requirements

  • Product development rationale and scientific background
  • Overview of biopharmaceutics (bioavailability, dissolution, food effects)
  • Overview of clinical pharmacology (PK, PD, dose-response, drug interactions)
  • Overview of efficacy (design, conduct, results of pivotal and supportive studies)
  • Overview of safety (common adverse events, serious adverse events, deaths, lab abnormalities, vital signs, special populations)
  • Benefits and risks conclusions with integrated benefit-risk assessment
  • Literature references

Expected Deliverables

  • Clinical overview document (~30 pages)

Page guidance: ~30 pages

ICH Guidelines: ICH M4E(R2)

Note: NDA only. ~30 pages, benefit-risk analysis

Source: ICH M4E

References

ICH M4E

Related Sections

Up toModule 2: Common Technical Document Summaries
2.1 — CTD Table of Contents

Table of contents for the CTD

2.2 — CTD Introduction

Brief introduction to the drug including pharmacological class and proposed indication

2.3 — Quality Overall Summary

Quality overall summary covering drug substance and drug product (40-80 pages for NDA)

2.4 — Nonclinical Overview

Nonclinical overview: integrated assessment of pharmacology, PK, and toxicology (~30 pages for NDA)

2.6 — Nonclinical Written and Tabulated Summaries

Nonclinical written and tabulated summaries covering pharmacology, PK, and toxicology (100-150 pages for NDA)

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