External Engagements with FDA for Artificial Intelligence in Drug Development

FDA encourages sponsors and other interested parties to engage early with FDA. There are various options for engagement with the agency, depending on how the sponsors or other interested parties intend to use the Artificial Intelligence (AI) model.

To discuss the use of AI in connection with a specific development program, sponsors may request an appropriate formal meeting. Please refer to the FDA guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products for more information.

The following list provides other engagement options depending on the intended use of the AI model. Where the meeting request covers a specific development program under investigational new drug application (IND) or a pre-IND, sponsors should include the IND or pre-IND number and notify the relevant review team of the meeting request.

CDER Center for Clinical Trial Innovation (C3TI)

Sponsors interested in discussing with CDER the use of AI in the design and conduct of late-stage pre-or post-marketing trial intended to support new drug approvals or changes to approved drug labeling.
Sponsors or other interested parties have non-product specific questions for CDER related to the use of AI in clinical trials and are unsure who to contact. C3TI will triage inquiries and connect individuals to the relevant CDER program or subject matter expert.
Email C3TI at CDERclinicaltrialinnovation@fda.hhs.gov.

Complex Innovative Trial Design Meeting Program (CID)

Sponsors interested in using AI in novel clinical trial designs.
Learn more about how to apply for the CID program.
FDA encourages sponsors to send an email to Meetings@fda.hhs.gov to provide notification that your CID meeting request application has been submitted.

Drug Development Tools (DDTs)

Sponsors or other interested parties interested in qualifying drug development tools that use AI.
Email CDER Biomarker Qualification Program at CDER-BiomarkerQualificationProgram@fda.hhs.gov.
Email CDER Clinical Outcome Assessment Qualification Program at COADDTQualification@fda.hhs.gov.
Email CDER and CBER Animal Model Qualification Program at CDERAnimalModelQualification@fda.hhs.gov.
Email CBER DDT Qualification Programs (includes Biologics Biomarkers and Clinical Outcome Assessments) at CBERDDTQualificationProgram@fda.hhs.gov.
Email the ISTAND Pilot Program at ISTAND@fda.hhs.gov.

Digital Health Technologies (DHTs) Program

Sponsors or other interested parties interested in using AI-enabled DHTs not associated with a specific drug development program and who would like to discuss general feasibility for their proposed DHT or for have general questions about the potential use of their DHT, email DHTsforDrugDevelopment@hhs.fda.gov. For questions related to a specific drug development program, the sponsor should contact the relevant review division.

Emerging Drug Safety Technology Program (EDSTP)

Sponsors or other interested parties interested in using AI in pharmacovigilance (PV). EDSTP is specifically focused on the use of AI in PV for postmarketing activities; it is part of CDER’s multifaceted approach to enhance mutual learning of where and how specific innovations, such as AI, can best be used throughout the drug product lifecycle.
EDSTP is not an avenue to seek regulatory advice on compliance with pharmacovigilance regulations. Questions about a specific development program should be addressed through other channels. Please email AIMLforDrugDevelopment@fda.hhs.gov with the subject line “EDSTP” for more information.

CDER’s Emerging Technology Program (ETP) and CBER’s Advanced Technologies Team (CATT)

Sponsors or other interested parties interested in uses of AI in pharmaceutical manufacturing.
Early engagement with the ETP or CATT is highly encouraged before submitting a regulatory application or implementing AI technology for drug or biological product manufacturing.
Please visit the Emerging Technology Program website for more information. Requests and proposals may be sent by email: For CDER regulated drugs CDER-ETT@fda.hhs.gov, and for CBER regulated biological products Biologics@fda.hhs.gov. Include “CATT” in the subject line.

Model-Informed Drug Development Paired Meeting Program (MIDD)

Sponsors interested in using Model-informed drug development using AI.
Sponsors with a pre-IND or an IND who are considering the application of MIDD approaches to the development and regulatory evaluation of medical products in development should visit the MIDD website for more information or email MIDD@fda.hhs.gov with “MIDD Program Meeting Package for CDER” (CDER applications) or “MIDD Program Meeting Package for CBER” (CBER applications) in the subject line.

Real-World Evidence (RWE) Program

Sponsors or other interested parties interested in using AI in a study using real-world data to produce RWE.
For more information on the CDER, CBER, or OCE RWE programs, please visit each center’s web page or contact CDER-RWE@fda.hhs.gov.

General AI Inquiries and CDER Listening Session Requests

For general inquiries related to the use of AI in drug development or CDER listening session requests, please email CDER-AI@fda.hhs.gov.