April 2023

The FDA will assist investigators who need consultation regarding when to submit an IND/IDE 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 intends to submit an IND or IDE application to the FDA, then the JH faculty member would be the sponsor/investigator of the IND or IDE, and would be responsible for abiding by all FDA regulations that apply to both Sponsors and Investigators, as well as the institutional policy on investigator-held INDs/IDEs.

Investigators who require consultation with the FDA to determine if an IND or IDE application is required are strongly encouraged to contact the Office of Clinical Trials (OCT) or schedule a consultation for assistance. The IND/IDE Regulatory Program of the OCT assists investigators seeking to serve in the role of sponsor-investigator and can assist with FDA consultations about the need for an IND/IDE.

Consulting with the FDA about the need for an IND:

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: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-new-drugs to determine the specific person at the FDA who can guide them.

FDA staff may be able to provide this advice through informal communications (e.g., phone conversation, e-mail). In other cases, FDA staff may request that the Sponsor submit a summary of their proposed investigation in writing for FDA review before providing advice. Where possible, it is best to obtain documentation of the FDA’s guidance (e.g. email or in writing) as the IRB may request this documentation as part of its review. 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 and download the final guidance document: https://www.fda.gov/media/79386/download.

The FDA division office may determine that the proposed investigation is exempt from the IND regulations, 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 proposed investigation. If the FDA requires an IND application, all documents 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: https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application.

Consulting with the FDA about the need for an IDE or for a risk determination for a device:

FDA Q-Submission Program: The FDA’s Q-Submission Program provides submitters an opportunity to have early collaboration and discussions about medical device submissions. The Center for Devices and Radiological Health (CDRH) has clarified the available ways submitters can request feedback or a meeting with the FDA about potential or planned medical device or device-led combination product submissions. CDRH has also shared feedback on opportunities for submitters to discuss issues communicated by the FDA during review of other submission types, such as submission hold letters. See FDA’s Guidance for Industry and Food and Drug Administration Staff, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: Q-Submission Guidance - Level 2 Update (fda.gov).

Need Assistance?

The OCT can facilitate, help investigators prepare for, and support discussions with FDA surrounding the requirement for the proposed investigation(s) to be conducted under an IND or IDE. Requests for support may be emailed to OCT at [email protected], or consultations may be scheduled directly with a program representative.