On March 20th, FDA is conducting a public workshop to discuss the use of complex innovative designs (CID) in clinical trials of drugs and biological products to inform regulatory decision making.
This meeting will inform development of a guidance document as required by the 21st Century Cures Act (Cures Act) and is being conducted to meet the performance goal of convening a public workshop on CID included in the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI), part of the FDA Reauthorization Act (FDARA). This meeting will also inform the development of a CID pilot program.
The purpose of this public meeting is to:
- facilitate discussion and information sharing about the use of CID in drug development and regulatory decision making
- obtain input from stakeholders about the CID pilot program.
FDA is seeking information and comments from a broad range of stakeholders. This website will be updated as meeting materials are developed.
Tuesday, March 20, 2018
8:30 a.m. – 5:00 p.m.
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31, Room 1503 (Great Room)
Silver Spring, MD 20993
(Information about arrival to FDA’s White Oak campus)
To register for this meeting, visit: https://complexinnovativedesigns.eventbrite.com/. Registration for in-person attendance will close on March 13, 2018.
If you are unable to attend the workshop in person, you can register to view a live webcast of the workshop. You will be asked to indicate in your registration if you plan to attend in person or via the webcast. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. However, FDA may limit the number of participants from each organization based on space limitations.
The webcast will begin streaming approximately one-half hour before the start of the meeting. A recording of the webcast as well as a transcript will be available on this meeting website approximately one month after the meeting takes place.
- Final Agenda: Promoting the Use of Complex Innovative Designs in Clinical Trials (PDF - 155 KB)
- Panelist Biographies (PDF - 337 KB)
- Slide Presentation: Promoting the Use of Complex Innovative Designs in Clinical Trials (PDF - 1 MB)
- Federal Register Notice
Transcript: Tuesday, March 20, 2018 (PDF - 1MB)
Public Docket: I
In addition to providing input at the public meeting, stakeholders are invited to submit comments through the public docket. The public docket will close on April 20, 2018.