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

Sen. Alexander Wants To ‘Start From Scratch’ In Regulating Lab-Developed Tests

Executive Summary

Senate HELP Committee Chair Lamar Alexander, R-Tenn., suggested he would prefer to “start from scratch” in developing appropriate regulatory controls for laboratory-developed tests, despite a proposed regulatory framework for US FDA for the tests that was more than a decade in the making. That triggered some debate at a Sept. 20 committee hearing.

Advertisement

Related Content

FDA Puts Lab-Developed Test Oversight Plans On Hold
FDA's New Cross-Cutting Oncology Center Gets Pazdur As Lead
CMS And FDA Stand Together Behind FDA Oversight Of LDTs At House Hearing
Molecular Pathologists Propose Third-Party Review Of High-Risk Dx In Alternative To FDA LDT Plan
Senators Circulate Plan For Standalone FDA Diagnostics Center, ‘In Vitro Clinical Test’ Rules

Topics

Related Companies

Related Deals

Advertisement
UsernamePublicRestriction

Register

MT103855

Ask The Analyst

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

All set! This Question has been sent to 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