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  1. CDER Emerging Drug Safety Technology Program (EDSTP)

Emerging Drug Safety Technology Meeting (EDSTM) Program

CDER Emerging Drug Safety Technology Program (EDSTP)

As announced in the Federal Register Notice on June 11, 2024, CDER has established a meeting program called the Emerging Drug Safety Technology Meeting (EDSTM) program. These meetings will be administered by staff in the newly established CDER EDSTP. The meeting program provides applicants with an approved application and/or other relevant parties supporting industry’s PV activities (e.g., academia, contract research organizations (CROs), pharmacovigilance vendors, software developers) who meet the eligibility and selection criteria for participation with an opportunity to meet with CDER staff to discuss their research, development, and use of AI and other emerging technologies in PV. The goals of the meeting program are to facilitate discussion and mutual learning of the pharmaceutical industry’s application of these technologies to PV. The EDSTM program is not an avenue to seek regulatory advice on compliance with pharmacovigilance regulations. Rather, we expect that the information gained during this program will help CDER consider providing regulatory advice on specific technologies to facilitate their adoption when appropriate.  The discussions and background information submitted through the EDSTM are nonbinding on both FDA and EDSTM requesters.

Eligibility Criteria

EDSTMs can be requested by applicants with at least one approved application regulated by CDER, including new drug applications (NDAs), abbreviated new drug applications (ANDAs), or biologics license applications (BLAs), and/or by other relevant parties supporting industry’s PV activities (e.g., academia, CROs/pharmacovigilance vendors, software developers) who develop, leverage, or intend to leverage AI or other emerging technologies that can be used to satisfy the postmarketing reporting requirements in 21 CFR 314.80, 314.98, and 600.80. Eligible applicants and other relevant parties, such as an applicant’s PV vendor may request meetings separately or in partnership. 

While the same technology may have utility for both pre- and post-market PV, the scope of the EDSTM program is for the use or potential use of such technologies for post-market PV. 

Submission Timeline and Process

FDA will grant EDSTM requests quarterly each calendar year for a total of up to nine participants in a 12-month period for the initial phase of the EDSTM. The quarterly submission deadlines for EDSTM requests are listed below. Eligible applicants and other relevant parties may submit EDSTM requests on a rolling basis. FDA will review all meeting requests received in the preceding 3-month submission cycle after each submission deadline.

Meeting Request Submission Deadline

October 1, 2024

January 1, 2025

April 1, 2025

July 1, 2025

CDER intends to respond to meeting requesters with the decision to grant, deny, or defer an EDSTM no later than 45 days after the submission deadline.  Incomplete and/or unclear requests will generally be denied. Where proposals of interest are unable to be accommodated within a quarter, CDER may defer consideration of the request to the following quarter.

How to Request an EDSTM 

To request a meeting, eligible parties should submit an email that includes their request with the subject line “Request for an EDSTM” to AIMLforDrugDevelopment@fda.hhs.gov. CDER will confirm receipt of an EDSTM request within three business days.

The meeting request should include the following items and not exceed five pages including figures and tables:

  • Name of the requester
  • Description of the organization
  • Meeting purpose, background, and a brief description of the proposed or current use of the emerging technology (e.g., AI) for PV
  • Topics for discussion

Please be advised when submitting a meeting request:

  • A request for an EDSTM should not be submitted to a regulatory application (e.g., IND, NDA, or BLA).
  • The EDTSM program does not cover the application of emerging technologies outside of PV, such as those used in clinical research
  • The EDSTM program is not an avenue to seek regulatory advice regarding the adequacy or acceptability of a drug safety technology that uses AI or other emerging technologies. Rather, we expect the information gained during this program will help CDER consider providing regulatory advice on specific technologies to facilitate their adoption when appropriate.

Selection Criteria

CDER welcomes eligible parties to submit meeting requests related to any topics relevant to the use of AI and other emerging technologies in PV. However, depending upon the availability of resources per quarter, the Agency will base its selection of requests on several considerations, including:

  • The Agency’s prior experience and knowledge about the topic
  • How uses/proposed uses can be used to satisfy regulatory obligations regarding PV
  • Tools that may inform approaches used by a broad set of parties
  • The relative stage of development and application of the technology within PV
  • The similarity of the technology to other technologies explored through the EDSTM program
  • Submissions that consider or discuss how the credibility and trustworthiness of an AI model(s) is established. (For more information see, What topics are of interest to CDER for EDSTMs?).

Meeting Package

If a meeting request is granted, the requester will be assigned a primary point of contact within the EDSTP who will facilitate meeting scheduling and administrative details.

Once the meeting is scheduled, the requester should submit a final meeting package no later than 2 weeks before the meeting date. The meeting package should be sent to AIMLforDrugDevelopment@fda.hhs.gov, using the subject line “EDSTM Meeting Package [name of company/vendor, name of technology]”, and include the following elements:

  • Objective of the meeting
  • Proposed agenda
  • Discussion topics
  • Presentation slides and/or additional background materials, if any, and
  • Requester attendees and respective position or title, and affiliations

Meeting Procedures

An EDSTM will be scheduled for up to 90 minutes. CDER will consider requests for follow-up meetings on a case-by-case basis. As noted, the discussions and background information submitted through the EDSTMs are nonbinding on both FDA and EDSTM requesters.

Contact Us

For more information regarding CDER’s Emerging Drug Safety Technology Program (EDSTP) and/or the Emerging Drug Safety Technology Meeting (EDSTM), please email AIMLforDrugDevelopment@fda.hhs.gov and include the subject line “EDSTM – General Inquiry”

 

 
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