Docket Number:
FDA-2019-D-3679
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This document provides guidance to sponsors and applicants on interacting with the FDA on complex innovative trial design (CID) proposals for drugs or biological products.   FDA is issuing this guidance to satisfy, in part, a mandate under section 3021 of the 21st Century Cures Act (Cures Act).  In accordance with the Cures Act mandate, this guidance discusses the use of novel trial designs in the development and regulatory review of drugs and biological products, how sponsors may obtain feedback on technical issues related to modeling and simulation, and the types of quantitative and qualitative information that should be submitted for review.  Additional recommendations related to the mandate set forth in section 3021 of the Cures Act are addressed in FDA’s guidance on Adaptive Designs for Clinical Trials of Drugs and Biologics (Ref. 1).   This guidance finalizes the draft guidance of the same title dated September 2019.

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All written comments should be identified with this document's docket number: FDA-2019-D-3679.

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Contact Point
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Center for Biologics Evaluation and Research
Food and Drug Administration
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