Innovative Science and Technology Approaches for New Drugs (ISTAND) Program Submission Process

Submission Process

The 21st Century Cures Act formally established a multi-step process for Drug Development Tools (DDT) qualification. Qualification of a DDT is for a specific context of use (COU), and the qualified DDT may be used for the COU by any person in drug or biologics development.

The qualification process includes three submissions:

the Letter of Intent (LOI),
the Qualification Plan (QP),
and the Full Qualification Package (FQP).

Letter of Intent (LOI)

Applicants to the ISTAND Program begin by submitting a Letter of Intent to ISTAND@fda.hhs.gov. Content Elements for the LOI can be found on the LOI Content Elements file.

Following receipt of a completed LOI, ISTAND Program staff will review the submission and provide the applicant with information as to whether the submission has been admitted into the program and will progress to technical review. Admittance will be based on submission quality, drug development need, technology feasibility, and subject matter expert capacity.

If an LOI is admitted for review, the applicant may be invited to present to the review staff. All such meeting proceedings will be confidential, and all discussions will be non-binding.

Next Steps

Following subject matter expert review, the DDT Committee makes the determination to accept or not accept a submission into the program based on several factors, including: the scientific merit of the submission, the ability of the DDT to address a specified drug development need, the availability of information and resources that support the proposed qualification effort, and demonstration that the DDT is feasible and practical. Although ISTAND’s goal is to qualify novel drug development tools for use in drug development programs, for some novel DDTs, qualification may not be the optimal path forward. In these cases, ISTAND will assist requestors and Agency subject matter experts to find the best path forward (e.g., guidance development or public meeting).

A determination to accept an LOI or a QP submission indicates that the requestor may proceed to the next stage, the QP or FQP, respectively, provided the requestor addresses the recommendations and comments in the Determination Letter. Applicants may not proceed from the LOI or QP stage to the next stage unless they are accepted at these stages.

The ISTAND Program offers two types of meetings: pre-submission meetings and debrief meetings.

Preliminary Qualification Meetings

A pre-submission meeting serves as an opportunity for requesters who plan to submit an LOI, QP, or FQP submission to the ISTAND, to receive non-binding advice from the FDA. A pre-submission meeting is a 30-45 minute video/teleconference to discuss topics such as requirements for the ISTAND Program, intended use of the tool, and other topics related to the tool’s potential qualification.

Requesting a Pre-LOI Meeting

To request a preliminary meeting, please email us at ISTAND@fda.hhs.gov. Your written request should include:

Cover Letter to the ISTAND which includes three proposed dates (within 60 days of your request) and proposed agenda for a 30-45 minute meeting.

Specific questions to the ISTAND in PowerPoint format. Please provide a 10-15 minute background slide presentation containing tool name, proposed Context of Use (COU), and Drug Development Need and any relevant information.

Draft Letter of Intent. Note, to assist you in preparing this draft, refer to the LOI content element outline. Although detailed information is not required at this stage, organizing your draft according to the outline will help you formulate any questions you may have for staff and better prepare for the upcoming meeting. Using this structure ensures a more efficient and productive review process.

In cases where it is not feasible to grant a meeting, we may provide you with written responses to your specific questions.

Requesting a Pre-QP or Pre-FQP Meeting

To request a Pre-QP or Pre-FQP meeting, please email us at ISTAND@fda.hhs.gov. Your meeting request should include:

Cover Letter to the ISTAND which includes three proposed dates (within 60 days of your request) and proposed agenda for a 30-45 minute meeting.

Draft QP or FQP. Although detailed information is not required at this stage, organizing your draft according to the outline will help you formulate any questions you may have for staff and better prepare for the upcoming meeting. Using this structure ensures a more efficient and productive review process.

Debrief Meetings

We also offer requestors the opportunity to request a debrief meeting following a decision letter issuance to clarify questions regarding the decision letter. The meeting is not an opportunity for the requester to bring up new topics unrelated to the response letter. A debrief meeting is a 30-45 minute teleconference intended to provide non-binding advice to requestors.

Requesting a Debrief Meeting

To request a debrief meeting, please email us at ISTAND@fda.hhs.gov. Your meeting request should include:

Cover Letter to the ISTAND which includes three proposed dates (within 60 days of your request) and proposed agenda for a 30-45 minute meeting.

Specific questions to the ISTAND in PowerPoint format and a 10-15 minute slide presentation with relevant information.

Draft resubmission addressing the FDA’s comments from previous submission decision letter. Although detailed information is not required at this stage, organizing your draft according to the outline will help you formulate any questions you may have for staff and better prepare for the upcoming meeting. Using this structure ensures a more efficient and productive review process.

In cases where it is not feasible to grant a meeting, we may provide you with written responses to your specific questions.