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US FDA Offers Sponsors More Attention For Sharing Complex Innovative Trial Designs

Executive Summary

Pilot program will select two trial designs per quarter, but sponsors want to know how much information they must disclose.

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US FDA, Industry Share Early Lessons From Complex Innovative Trial Designs Program

Timelines in the CID program are tight, and sponsors should have a ‘fully baked’ trial design before heading into their first meeting with the agency, industry reps say; agency needs more simulation data from participating sponsors earlier and is working to ensure continuity for firms after the second of two meetings allowed under the program.

Innovative Trial Designs Are 'Life And Death Matter' For Pharma, Amgen Tells US FDA

Amgen exec calls for more informal agency feedback and alignment between review divisions in understanding design methodologies.

US FDA's Complex Trial Design Pilot May Change 'Ambitious' Timelines

Program allows eight months for sponsors to be accepted and conduct two meetings with FDA on an innovative design, but the agency said more time may be needed.

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