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# Drug Complex Innovative Design Meeting Pilot
- URL: https://www.fdaweb.com/drug-complex-innovative-design-meeting-pilot/
- Published: 2018-08-29T12:00:00.000Z
- Updated: 2026-09-15T00:28:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142222

As required under PDUFA 6, FDA is implementing a pilot meeting program that affords drug sponsors who are selected the opportunity to meet with agency staff to discuss using complex innovative trial design (CID) approaches in medical product development. An 8/30 *Federal Register* [notice](https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-18801.pdf?ref=fdaweb.com) says the [pilot](https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM617212.htm?ref=fdaweb.com) will run through 9/30/2022\. Sponsors may submit meeting requests through 6/30/2022.

The notice says the goal of the early meeting discussions granted under the pilot is to provide advice on how a proposed CID approach can be used in a specific drug development program and to promote innovation by allowing FDA to publicly present the trial designs considered through the pilot program, including trial designs for drugs that have not yet been approved by FDA. The agency has committed to accepting up to two meeting requests quarterly each fiscal year. The meetings granted will include an initial and follow-up meeting on the same CID and medical product within the span of about 120 days. The notice cautions that being granted a meeting does not mean that the proposed CID is appropriate for regulatory decision-making, while being denied a meeting does not mean that the proposed CID is unacceptable for regulatory decision-making.