Response: The CID Paired Meeting Program is the PDUFA VII continuation of the CID Pilot Meeting Program established under the sixth iteration of the Prescription Drugs User Fee Amendments (PDUFA VI). For the PDUFA VI timeframe (fiscal years 2018 through 2022), FDA agreed to conduct a pilot meeting program for highly innovative trial designs for which analytically derived properties may not be feasible, and simulations are necessary to determine trial operating characteristics (e.g. Type 1 error). The meeting program continuation under PDUFA VII was announced in the Federal Register on October 20, 2022. The meeting program supports the goal of facilitating and advancing the use of complex adaptive, Bayesian, and other novel clinical trial designs.

This program offers sponsors who are selected an opportunity for increased engagement with FDA experts from the Center for Drug Evaluation and Research (CDER) and/or Center for Biologics Evaluation and Research (CBER) to discuss CID and analyses in medical product development.