Zdrowie i gospodarka · 04/02/2019

FDA Releases Final Guidance on Labeling for Human Prescription Drugs Approved Under Accelerated Approval Pathway

The US Food and Drug Administration (FDA) has released a final guidance document titled 'Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway.' This document outlines the FDA's recommendations for labeling human prescription drugs and biological products that were approved under the accelerated approval pathway, which allows for faster approval of life-saving treatments. The guidance finalizes a draft document released in March 2014.