Scrip is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


FDA Companion, Co-Development Dx Guidances On Track, Official Says

This article was originally published in The Gray Sheet

Executive Summary

FDA aims to issue both a final companion diagnostics guidance document and a separate draft guidance on the co-development of drugs and tests in the coming months.


Related Content

FDA’s Upcoming Drug/Diagnostic Co-Development Guidance Could Quickly Become Outdated
Utility Before Profitability: The Evolving Evidence Paradigm For Molecular Diagnostics
CDRH In 2012: More Pilots, Guidances And Regs
CDRH’s Mansfield Addresses Upcoming Drug/Dx Co-Development Guidance
Views Differ On How Lab-Developed Tests Fit In FDA Companion Dx Guidance
FDA Companion Dx Draft Guidance: Broad In Scope, Limited In Detail





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts