Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product: Draft Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Biologics, Drugs, IVDMD, Medical Devices
Topics
Premarket
Published
July 15, 2016
Last updated
May 14, 2019
Description
This document is a draft guidance for the development of in vitro companion diagnostic devices with therapeutic products, aimed at industry and FDA staff.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)