Zdrowie i gospodarka · 15/07/2016

Principles for Codevelopment of an In Vitro Companion Diagnostic Device With a Therapeutic Product; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product." This draft guidance is intended to be a practical guide to assist therapeutic product sponsors and in vitro diagnostic device (IVD) sponsors in developing a therapeutic product with an accompanying IVD companion diagnostic, a process referred to as codevelopment. This draft guidance is also intended to assist FDA staff participating in the review of such IVD companion diagnostics or their associated therapeutic products. This draft guidance is not final nor is it in effect at this time.