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.
FDA to Launch National Priority Voucher Program to Speed Drug Reviews for Critical Therapies
June 18th 2025Under the new initiative, companies may receive a voucher enabling FDA review to be shortened from the standard 10–12 months to just 1–2 months following final application submission if the drug addresses US national health priorities.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.