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Complex Innovative Trial Design Meeting Program

As displayed in the Federal Register notice on October 20, 2022, FDA is continuing the Complex Innovative Trial Design (CID) Paired Meeting Program, originally established under PDUFA VI, to support the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs. The CID Paired Meeting Program fulfills a performance goal agreed to by the Prescription Drug User Fee Act (PDUFA) reauthorization for fiscal years (FYs) 2023-2027, known as PDUFA VII.

This paired meeting program offers sponsors whose meeting requests are granted the opportunity for increased interaction with FDA staff to discuss their proposed CID approach.

Meetings 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 to 2027. To promote innovation in this area, trial designs developed through the meeting program may be presented by FDA (e.g., in a guidance or public workshop) as case studies, including trial designs for medical products that have not yet been approved by FDA.

Advancing the Use of Complex Innovative Trial Designs (CID)

An introduction and overview of FDA’s CID Paired Meeting Program [Introduction Slides (PDF - 949 KB)]

Complex Innovative Trial Designs (CID) Paired Meeting Program Process

Learn about the CID Paired Meeting Program’s process and what to expect [Process Slides (PDF - 886 KB)]

Goals of the CID Paired Meeting Program

The CID Paired Meeting Program is designed to:

  • Facilitate the use of CID approaches with emphasis in late-stage drug development.
  • Promote innovation by allowing FDA to publicly discuss the trial designs accepted by the paired meeting program, including trial designs for medical products that have not yet been approved by FDA.

Procedures and Submission Information

CID Paired Meeting Program
Quarterly meeting request submission deadlines
March 31 June 30 Sept. 30 Dec. 31

Applicants will be notified of eligibility to proceed to disclosure discussions within 45 days after submission deadlines.

Under the CID Paired Meeting Program, FDA will select 1-2 eligible and appropriate proposals per quarter each year (i.e. up to 8 per year). For each meeting request granted, FDA will conduct an initial meeting and a follow-up meeting on the same CID proposal. The second meeting will occur within approximately 90 days after receiving the briefing materials.

  • Meeting requests should be submitted electronically to the relevant application (i.e., Pre-IND, IND) with “CID Program Meeting Request for CDER” (CDER applications) or “CID Program Meeting Request for CBER” (CBER applications) in the subject line.
  • Review the information about providing regulatory submissions in electronic format.

Frequently Asked Questions

Visit Complex Innovative Trial Design Paired Meeting Program Frequently Asked Questions for more information about the program.

Contact Us

For submission assistance and inquiries about the CID Paired Meeting Program, email: CID.Meetings@fda.hhs.gov.
This mailbox is monitored daily and replies will be sent within two business days of receipt.

CID Paired Program Trial Design Case Studies

The description of each CID Paired Meeting Program case study focuses on the single clinical trial design that was the subject of the submission. The description does not discuss other potentially important aspects of the development program for the respective drug or biologic, such as any plans to conduct additional adequate and well-controlled trial(s) and/or to obtain confirmatory evidence to help establish substantial evidence of effectiveness. Please refer to draft guidance Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products (December 2019).

Learn More about CID

FDA Guidance


Public Meetings

Other Communications

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