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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.

For more information or questions: IND_IDEprogram@jh.edu.

Johns Hopkins University "JHU" Investigator-held IND/IDE Review Procedures

An Investigator-held IND/IDE Review Procedures Overview flowchart is available.

Step 1:  IND/IDE Holder Review

  • 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.

Step 2:  Planning Phase Application

  • 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

Step 3: IND/IDE Application Submission to the FDA

  • 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.

Step 4: IRB Application

  • 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.

Regulatory Resources:

Regulatory Requirements for an IND Application:

Regulatory Requirements for an IDE Application

Presentations

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