Zdrowie i gospodarka · 15/07/2016

FDA Releases Draft Guidance for Codevelopment of In Vitro Companion Diagnostic Devices with Therapeutic Products

The Food and Drug Administration (FDA) has released a draft guidance document titled 'Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product.' This document aims to assist companies in developing therapeutic products with accompanying in vitro diagnostic devices, a process known as codevelopment, and is intended for both industry sponsors and FDA staff reviewing these products.