FDA upgrades guide for 'breakthrough' status, other expedited programs
This article was originally published in Scrip
Executive Summary
Less than a year after releasing a guidance for four programs aimed at facilitating and expediting development and review of new drugs intended to address unmet medical needs for serious and life-threatening conditions, the FDA has finalized the document, upgrading its thinking on what biopharmaceutical makers need to do to meet the criteria for fast-track status, accelerated approval, priority review and the breakthrough therapy designation.