Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators

Issue Date: May 15, 2015
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural
Status: Draft

Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators

The purpose of this guidance is to assist sponsor-investigators in preparing and submitting complete investigational new drug applications (INDs) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). Sponsor-investigators seeking to do clinical research often do not have the regulatory knowledge or the resources to hire experts to help them with the IND submission process. Although not an exhaustive step-by-step instruction manual, this guidance highlights certain elements of this process to facilitate a sponsor-investigator’s successful submission of an IND. This guidance also discusses the IND review process and general responsibilities of sponsor-investigators related to clinical investigations.

Download the Guidance Document