Zdrowie i gospodarka · 03/06/2016

FDA Releases Guidance for Individual Patient Expanded Access Applications

The Food and Drug Administration (FDA) has released a guidance document titled "Individual Patient Expanded Access Applications: Form FDA 3926" for industry professionals, outlining the process for submitting Individual Patient Expanded Access Applications (INDs) for investigational new drugs. This guidance streamlines the process for requesting expanded access to INDs for individual patients with serious or life-threatening conditions, allowing for emergency use and providing a streamlined alternative for submitting INDs.