Posted by Michael Wonder on 22 Sep 2019
Interacting with the FDA on complex innovative trial designs for drugs and biological products
20 September 2019 - This document provides guidance to sponsors and applicants on interacting with the FDA on complex innovative trial design proposals for drugs or biological products.
The FDA is issuing this guidance to satisfy, in part, a mandate under section 3021 of the 21st Century 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 modelling and simulation, and the types of quantitative and qualitative information that should be submitted for review.
