Business · 03/10/2019

FDA Releases Final Guidance for Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment

The Food and Drug Administration (FDA) has released a final guidance document for industry, titled 'Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment,' which provides guidance on designing and conducting nonclinical studies to support the development of enzyme replacement therapy (ERT) products. This guidance incorporates comments received since its initial release on May 13, 2015.