Module 5 Presentations

18/07/2024

IND in eCTD

Cover letter; Table of Contents, FDA forms (administrative docs), Investigational Brochure, draft label, General Investigational Plan

M1

Summaries: Introduction, Quality, Nonclinical, Clinical

M2

Quality: Drug Substance, Drug Product(s)

M3

M4 Nonclinical reports and associated literature references

Clinical reports, protocols, ICFs, investigator documents; safety reports M5

The Organisation for Professionals in Regulatory Affairs

9

IND Components

Module 1 (Administrative Information), including (but not limited to): ● Cover letter ● Investigational Brochure

● Investigational drug labeling ● General investigational plan ● Transfer of obligations ● Any FDA correspondence (pre-IND)

● Forms 1571 & 3674 ● Environmental waiver FDA eCTD - The Comprehensive Table of Contents Headings and Hierarchy

The Organisation for Professionals in Regulatory Affairs

10

5