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Investigator Inquiry to the FDA About the Need for an Investigational New Drug Application (IND)

September 2020

The FDA will assist investigators who need consultation regarding when to submit an IND application before starting a research study. Most commonly, this question arises when an investigator wants to use an FDA approved product off-label. If a JH faculty member submits an IND application to the FDA, then the JH faculty member would be the sponsor/investigator of the IND, and would be responsible for abiding by all FDA regulations that apply to both sponsors and investigators.

FDA Pre-IND Consultation Program: The FDA, Center for Drug Evaluation and Research (CDER) offers a pre-IND application consultation program to foster early communications between sponsor/investigators of IND applications and the new drug review divisions of CDER in order to provide guidance on the data necessary to warrant a submission of an IND application. Depending on the type of study, sponsor/investigators can go to the FDA Center for Drug Evaluation and Research link: to determine the specific person at the FDA who can guide them.

The FDA division the investigator contacts may or may not be able to assess the IND request over the telephone, and will inform the investigator as to what information will be required. See FDA Guidance for Industry: Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND, Section VIII. Process for Addressing Inquiries Concerning the Application of IND Requirements:

The FDA division office may determine that the IND is exempt, in which case the investigator will receive a letter to that effect. This letter must be uploaded into the eIRB application going to the JHM IRB. If, on the other hand, the FDA determines that an IND application is required, the FDA would already have the paperwork necessary for the IND application submission, and can proceed directly to review the application to determine whether an IND could be granted for the protocol. If the FDA requires an IND application, all document from the FDA and from the JHM faculty member who is also the sponsor/investigator of the IND must be uploaded into the eIRB application.

For general IND information, please refer to the FDA’s Investigational New Drug (IND) Application process site: