An Investigational New Drug (IND) application to the FDA is required to initiate first in human clinical trials in the US. The IND is amended over the life of the drug development process with the end goal of filing a New Drug Application (NDA) for marketing approval. This presentation reviews the initial IND requirements in an electronic Common Technical Document (eCTD) format, the typical data that various disciplines (e.g. nonclinical, clinical, manufacturing and regulatory) contribute to each IND section, and using this data to support an ex-US regulatory submission. Clinical Operations, typically contributing the investigator’s brochure (IB) and protocol, is often responsible for collaborating with Regulatory to manage the initial regulatory filing and maintenance. Best practices for doing this, and to use the initial IND to create applications to initiate clinical trials outside the US will also be discussed.

Learning Objectives: 1) Define the initial IND requirements in a eCTD format 2) Describe Clinical contributions to the IND 3) Explain how IND documents can be used to initiate ex-US clinical studies 4) Identify documents required for IND maintenance