Investigational New Drug or Biologic

Detailed guidance to assist in preparing and maintaining an Investigational New Drug submission.

1. What is an IND?

An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Following preclinical benchwork, conducting investigations under an IND is the first step to getting a new drug approved for marketing by the FDA.

2. Is My Study Exempt?

Not all clinical studies need to operate under an IND. Use the decision tree to determine whether a proposed investigation will require IND submission and FDA oversight.

3. Getting Started with an Initial IND Submission

Preparing an IND submission can seem daunting. Downloadable templates and detailed descriptions of IND submission documents can help simplify the task. The initial IND submission to the FDA will provide the reviewers with the information necessary to conduct a thorough evaluation of the safety of the investigation, and its scientific merit. The submission is divided into several sections. The summaries listed in this page provide detailed instructions to prepare a complete IND submission.

4. FDA Responses and Type B Meetings

After the initial IND application is submitted, the FDA's review can lead to several possible outcomes. This page itemizes potential FDA responses and the steps an investigator should take in each situation. This page also describes Type B meetings and their associated timelines.

5. IND Maintenance

Once an IND submission has been approved, the FDA still requires periodic updates to evaluate the continued safety of the investigation. The Principal Investigator is responsible for notifying the FDA of any changes to the study protocol, site(s), or principal investigator. Some changes require approval prior to implementation. Additionally, any serious adverse events should be reported. This page details the actions that need to be taken to maintain an IND submission with the FDA.

To learn more about IND sponsor and investigator responsibilities, please view the ReGARDD Training Modules on IND Sponsor and Investigator Responsibilities.

6. Drug Development

Bringing an investigational drug from bench to bedside is a long, complicated process involving many nonclinical and clinical investigations and layers of regulatory oversight. This page provides an easy-to-follow timeline for the life cycle of a new drug and detailed descriptions for the whole process.