Model-Informed Drug Development Paired Meeting Program
More Information
The FDA is conducting a Model-Informed Drug Development (MIDD) Paired Meeting Program that will build on the success of the MIDD Paired Meeting Pilot by continuing to advance and integrate the development and application of exposure-based, biological, and statistical models derived from preclinical and clinical data sources in drug development and regulatory review. MIDD approaches use a variety of quantitative methods to help balance the risks and benefits of drug products in development. When successfully applied, MIDD approaches can improve clinical trial efficiency, increase the probability of regulatory success, and optimize drug dosing/therapeutic individualization in the absence of dedicated trials. The MIDD Paired Meeting Program affords sponsors who are selected for participation the opportunity to meet with Agency staff to discuss MIDD approaches in medical product development. Meetings under the program will be conducted by FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) during fiscal years 2023-2027.
What's New
The FDA announced the availability of the ICH M15 General Principles for Model-Informed Drug Development guidance in June 2026. This guidance is intended to facilitate a multidisciplinary understanding of MIDD and associated evidence generation to support drug development and regulatory decision-making. The guidelines describe the principles of MIDD, including recommendations on MIDD planning, model evaluation, and evidence documentation. Use of this guidance in preparing meeting requests and packages is recommended.
MIDD Meeting Program Email: MIDD@FDA.HHS.GOV
Goals of the MIDD Paired Meeting Program
The MIDD Paired Meeting Program fulfills a performance goal agreed to under the seventh iteration of the Prescription Drug User Fee Act (PDUFA VII), included as part of the FDA Reauthorization Act of 2023.
The MIDD Paired Meeting Program is designed to:
- Provide an opportunity for drug developers and FDA to discuss the application of MIDD approaches to the development and regulatory evaluation of medical products in development, and
- Provide advice about how particular MIDD approaches can be used in a specific drug development program
Procedures and Submission Information
Under the paired meeting program, FDA will accept 1-2 paired-meeting requests quarterly each year throughout the PDUFA VII period. Additional proposals that meet the eligibility criteria may be selected depending upon the availability of resources. For each meeting request granted as part of the paired meeting program, FDA will conduct an initial and follow-up meeting on the same drug development issues.
Eligibility Criteria
- Drug/Biologics development company with an active IND or PIND number for the relevant development program
- Interested consortia or software/device developer should come in partnership with a drug development company
- This excludes statistical designs involving complex adaptations, Bayesian methods, or other features requiring computer simulations to determine the operating characteristics of a confirmatory clinical trial
Selection for Participation
FDA welcomes submissions related to any relevant MIDD topics. However, given that the Agency expects to grant 1-2 meeting requests with additional proposals depending upon the availability of resources per quarter, the Agency will initially prioritize selecting requests that focus on:
- Dose selection or estimation (e.g., for dose/dosing regimen selection or refinement)
- Clinical trial simulation (e.g., based on drug-trial-disease models to inform the duration of a trial, select appropriate response measures, predict outcomes, etc.)
- Predictive or mechanistic safety evaluation (e.g., use of systems pharmacology/mechanistic models for predicting safety or identifying critical biomarkers of interest)
Submission Dates and Decisions
Next Quarterly Due Dates:
| Meeting Request Submission Due Date | Meeting Request Grant/Deny Notifications Sent |
|---|---|
| March 1, 2026 | April 1st thru 8th 2026 |
| Meeting Request Submission Due Date | Meeting Request Grant/Deny Notifications Sent |
|---|---|
| June 1, 2026 | July 1st thru 9th 2026 |
| Meeting Request Submission Due Date | Meeting Request Grant/Deny Notifications Sent |
|---|---|
| September 1, 2026 | October 1st thru 8th 2026 |
| Meeting Request Submission Due Date | Meeting Request Grant/Deny Notifications Sent |
|---|---|
| December 1, 2026 | January 4th thru 11th 2027 |
Quarterly submissions will now be due on the 1st of the month. FDA will accept requests to participate in the program on a quarterly basis through June 1, 2027.
Submission Process
Meeting requests should be submitted electronically to the relevant application (i.e., PIND, IND) with either “MIDD Program Meeting Request for CDER” (CDER applications) or “MIDD Program Meeting Request for CBER” (CBER applications) in the subject line. Information about providing regulatory submissions in electronic format is available at: Electronic Common Technical Document (eCTD)
In addition, please send an email to MIDD@FDA.HHS.GOV providing notification your meeting request has been submitted to the relevant application.
Content & Format of the Meeting Request
Include the following information in the meeting request (no more than three to four pages):
- Product name
- Application number
- Chemical name and structure
- Proposed indication(s) or context of product development
- Brief statement of the question in the study or development program (i.e., question of interest) underlying the agenda. The question of interest can be related to dose/dosing, clinical trial simulation, or predictive or mechanistic safety.
- MIDD approach(es) (e.g., population pharmacokinetic, exposure-response, physiologically-based pharmacokinetic, drug-trial-disease, systems pharmacology/mechanistic modeling) considered for the product under development and how MIDD will be used to address the question of interest (i.e., context of use) and inform regulatory decision-making. The context of use could be, for example: to select or refine dose/dosing regimen, inform trial duration, select appropriate response measures, predict outcomes, predict safety or identify critical biomarkers of interest.
- Purpose and objectives of the meeting (i.e., what are the specific questions to the Agency about the MIDD approach for the applicable drug development program)
- Brief description of the key assessment elements (i.e., question of interest, context of use, model influence, consequence of wrong decision, model risk) as described in the guidance: M15 General Principles for Model-Informed Drug Development
Content & Format of the Meeting Information Package
Sponsors whose meeting requests are granted as part of the paired meeting program should submit a meeting information package electronically with either “MIDD Program Meeting Package for CDER” (CDER applications) or “MIDD Program Meeting Package for CBER” (CBER applications) in the subject line. Meeting Packages are due no later than 47 days before the initial (first) meeting. After the initial meeting has been held, the follow-up (second) meeting will be scheduled to occur within approximately 60 days of receiving the meeting package.
Meeting background packages should include the following information:
- Product name
- Application number
- Chemical name and structure
- Proposed indication(s) or context of product development
- Background section that includes a brief history of the development program and the events leading up to the meeting, and the status of product development
- Proposed agenda, including estimated times needed for discussion of each agenda item
- Questions for discussion with a brief summary of each question explaining the relevance to the MIDD approach and how the Agency can help guide any next steps relative to the regulatory decision-making process
- The table for assessment of MIDD evidence described in the guidance: M15 General Principles for Model-Informed Drug Development (Appendix 1)
- Other information and data imperative to support discussion
Meeting Summaries
A meeting summary will be sent to the requester within 30 days of each meeting
Submission Assistance
For more information, contact FDA at 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.