Medtech Insight 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

UsernamePublicRestriction
UsernamePublicRestriction

Clinical Labs Lawyer Up In Battle Over LDTs

This article was originally published in The Gray Sheet

Executive Summary

ACLA has recruited Laurence Tribe and Paul Clement, two prominent constitutional legal guns with Supreme Court expertise, to fight FDA over its proposed lab-developed test guidance. The announcement is perhaps the lab industry's most high profile move yet to oppose FDA's plan to regulate lab-developed test services under the device statute with a risk-based phase-in plan.

Advertisement

Related Content

Take Care In Promoting Lab-Developed Genetic Tests Or Risk US FDA, FTC Ire
Don't Finalize LDT Guidance, House Appropriators Tell FDA
Shuren In The Lion’s Den: Device Center Chief Defends LDT Plan At Clinical Lab Meeting, Fields Wide Array Of Questions
Congress Will Not Tinker With FDA LDT Guidance Before Final, Staffers Indicate
Coalition Expects Higher Personalized Medicine Profile During User Fee Talks
Shuren: LDT Reliability Critical To Precision Medicine Initiative
Shuren: LDT Reliability Critical To Precision Medicine Initiative
FDA Releases LDT Regulatory Framework, Notification Draft Guidances
FDA Plan To Regulate LDTs Includes Long Phase-In, Unmet-Need Exceptions
Senators Push OMB For Lab-Developed Test Guidance, Academic Labs Resist

Topics

Advertisement
UsernamePublicRestriction

Register

MT033519

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

Cancel