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. An IND must be authorized prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application.
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.
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 will provide detailed instructions to prepare a complete IND submission.
Sponsors should review the guidance Formal Meetings with Sponsors and Applicants for PDUFA Products for information on formal meetings with sponsors and applicants. After the IND submission has been delivered to the FDA, it undergoes a review process with several possible outcomes. This page itemizes potential FDA responses and the steps an investigator should take in each situation.
Once an IND submission has been approved, the FDA still requires periodic updates to evaluate the continued safety of the investigation. The sponsor 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.
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.
IND Regulations are found in Title 21 of the Code of Federal Regulations (CFR), Part 312 (21 CFR 312 ). Additional regulations that apply to INDs are found in 21 CFR as follows:
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This page last updated on 05/08/2023