FDA CID Paired Meeting Requests for Q3 Open
Designed to facilitate and advance the use of complex adaptive, Bayesian, and other novel clinical trial designs, the program provides an opportunity for sponsors to interact with experts from FDA.
The FDA's Complex Innovative Trial Design (CID) Paired Meeting Program is accepting meeting requests for this quarter until September 30, 2023. The CID Paired Meeting Program is designed to facilitate and advance the use of complex adaptive, Bayesian, and other novel clinical trial designs. Led by FDA statisticians with participation from relevant offices across the agency, the CID Paired Meeting Program provides an opportunity for sponsors to interact with experts from FDA at two meetings designed specifically to discuss their proposed CID. Meeting requests may be submitted on a rolling basis and must be received by the last calendar day of each quarter. More information about the program and to submit a meeting request is available at the Complex Innovative Trial Design Paired Meeting Program web page.
Reference: FDA Roundup, July 21, 2023.
Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.
