The Investigational New Drug (IND) application is a submission to the Food and Drug Administration (FDA) through which the sponsor seeks approval to conduct clinical studies with an investigational drug.

The IND application is the crucial stepping stone from non-clinical to clinical testing. The IND must contain information on a number of areas including animal pharmacology, drug distribution, toxicology, manufacturing, and the clinical protocol.

This module will provide regulatory professionals with the background and necessary detail needed to complete and submit an IND application for FDA approval.


Who will benefit from this module?
This module is primarily aimed at Regulatory professionals who are new to the IND application process. Professionals in clinical research, data processing, project management and marketing, and those whose role involves interaction with the FDA will also benefit from this module.

Individuals, within the pharmaceutical and biotechnology industries, who desire a greater understanding of writing regulatory submissions for the approval of products, will also find this module valuable.