Pink Sheet 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


Companion Diagnostics Guidance Finalized, But Lab Test Enforcement To Be Key

Executive Summary

FDA makes very few revisions from its three-year-old draft, but simultaneously releases the much-delayed proposal to begin actively regulating lab-developed tests, which presents important underlying questions for personalized medicine.


Related Content

Molecular Pathologists Propose Third-Party Review Of High-Risk Dx In Alternative To FDA LDT Plan
Diagnostics In 2014: More Of The Same
Lawmakers Seek Input On Dx Regs, With Lab-Developed Tests In Focus
Lab Groups’ LDT Comments Will Highlight Barriers To Test Accessibility
FDA Plan To Regulate LDTs Includes Long Phase-In, Unmet-Need Exceptions
FDA’s Upcoming Drug/Diagnostic Co-Development Guidance Could Quickly Become Outdated





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