Investigational New Drug (IND)/ Investigational Device Exemption (IDE) Regulatory Program
The Investigational New Drug (IND)/Investigational Device Exemption (IDE) Regulatory Program provides guidance to clinical investigators, sponsors, and sponsor-investigators regarding the process to secure institutional approval to serve in the role of sponsor-investigator and submit an application for an IND or IDE to the FDA in accordance with the institutional policy on Investigator-held INDs/IDEs.
The policy does not apply to IND/IDE applications submitted to the FDA before the effective date, IND/IDE exempt studies, or emergency/compassionate use requests for single patients. Read answers to frequently asked questions.
Johns Hopkins University "JHU" Investigator-held IND/IDE Review Procedures
An Investigator-held IND/IDE Review Procedures Overview flowchart is available.
Sponsor-Investigators must complete the investigator qualification process and be approved to serve as an IND/IDE holder. This approval process is only required once and may be completed at any time. Please complete the investigator qualification survey.
- Sponsor-Investigators (IND/IDE holders) must submit a Planning Phase Application to the Johns Hopkins Medicine - Institutional Review Board (JHM eIRB) to initiate institutional review of requests to submit a new IND/IDE application. A Planning Phase Application must be approved by the Office of Clinical Trials (OCT) prior to submission to the FDA.
- Investigators should follow these step by step instructions for completion of the planning phase application.
- Each planning phase application must include the IND/IDE Supplemental Form required for eIRB planning phase applications.
- The Investigational New Drug (IND) Application | FDA contains information from the FDA to assist you in the IND application process. Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.
- The IDE Approval Process | FDA contains information from the FDA to assist you in the IDE application process. Upon receipt of an IDE application, sponsors are notified via email of the date that the FDA received the original application and the IDE number assigned. An IDE application is considered approved 30 days after it has been received by the FDA, unless the FDA otherwise informs the sponsor via email prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved. In cases of disapproval, a sponsor has the opportunity to respond to the deficiencies and/or to request a regulatory hearing under 21 CFR Part 16.
- IND Applications for Clinical Investigations: Regulatory and Administrative Components
- Investigator-Initiated IND Applications webpage: Resources for application reporting and applications procedures for IND applications for both clinical research and clinical treatment
- Resources for the legal requirements of an IND application, IND review principles, policies and procedures
- Investigator’s Checklist for IND application submission
- FDA IDE Application Required Elements
- eCopy guidance document, refer to section V, Table 1. page 6-7.
- You may find it useful to review the following resources for e-Copy:
In accordance with DHHS regulations 45 CFR Part 46 and FDA regulations CFR Title 21 Part 56, convened IRB review is required for the majority of new applications submitted to the JHM IRBs. A convened meeting is one at which a majority of members must be present, including a member whose primary concern is in a non-scientific area, before official actions may be taken. In order for the research application to be approved, it must receive approval of a majority of those members present at the meeting. The processing time for a protocol requiring convened review varies, depending upon how complete the application is at submission.
- The JHM Office of Human Subjects Research - Institutional Review Board guidelines. Research Using FDA Test Articles
- The JHM Office of Human Subjects Research - Institutional Review Board guidelines for Investigational Medical Devices
- The JHM Office of Human Subjects Research - Institutional Review Board policies.
- Fees for JHM IRB Review
Investigational Drug, Biologic, and Device template documents are available to members of the Johns Hopkins research community, and are meant to serve as a guide for preparation of regulatory submissions to FDA. To improved the quality of regulatory submissions, increase efficiency and reduce delays in obtaining regulatory approval, and mitigate risk, we recommend partnering with a representative of the IND/IDE Regulatory Program prior to submission to FDA. Email us at [email protected], or schedule a consultation.
Education and Training
- The Compliance Monitoring Program is offering quarterly educational seminars. The fourth in the series, "Sponsor-Investigators (IND/IDE holders) institutional requirements," be held virtually on November 9, 2022. The sessions are open to all research staff and will count towards the in-person requirements for Investigator HSR recertification.
- General Introduction to IND/IDE regulations and responsibilities for sponsor-investigators