> , Training > FDA Guidance for Industry: Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment

FDA Guidance for Industry: Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment

The purpose of this guidance is to help sponsors design and conduct nonclinical studies during development of investigational enzyme replacement therapy (ERT) products. Specifically, this guidance describes the Food and Drug Administration’s (FDA’s) current thinking about the substance and scope of nonclinical information needed to support initiation of clinical trials, ongoing clinical development, and marketing approval for investigational ERT products.

 

Posted on the FDA website on 2 October 2019

2019-10-10T22:16:47+00:0010.10.2019|Regulatory Affairs, Training|