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The new guidance provides information on how sponsors should interact with the agency regarding complex innovative trial design proposals.
FDA published final guidance on Dec. 16, 2020 to provide sponsors and applicants information on how to interact with the agency regarding complex trial design (CID) proposals for drugs and biologics. The guidance is issued as a mandate under section 3021 of the 21st Century Cures Act (Cures Act) and “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,” according to the agency.
The guidance discusses meeting availability, recommended common elements of CID proposals, recommended elements of Bayesian CID proposals, and simulations. It also provides examples of CID and information recommended to facilitate interactions.