Orphans Wanted: FDA Offers New Ideas For Rare Disease Drug Development
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Top review managers tell NORD conference they are eager to find ways to accelerate development and comercialization of orphan drugs. CDER’s Woodcock suggests new partnership models focused on translational researc h as key component. CBER’s Yetter notes flexibility of regulatory standards and creative ideas for trial design