Medtech Insight is part of the Informa 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


Unfinished Business: LDT Legislation A Top Priority For Departing FDA Chief Gottlieb

Executive Summary

In a farewell talk at the Brookings Institution, outgoing US FDA Commissioner Scott Gottlieb said a top unfinished business that he hopes gets done after his April departure is legislation to regulate laboratory developed tests. While FDA had been looking to issue guidance on LDTs, he argues there isn’t sufficient legal authority for the agency to regulate the sector.


Related Content

Sharpless Confirms Interest In Being Permanent Commish
Tissue-Agnostic Cancer Treatments: Can US FDA-Approved Diagnostics Limit Access?
‘Disease Doesn’t Respect Silos’: Sharpless Sets Flexibility As Priority
NCI Director And Former Dx Start-Up Founder Sharpless Will Helm FDA
US FDA Inspection Goals Reduced After Shutdown; Review Dates Look Safe
ACLA Rejects FDA As A ‘Clinical Validity’ Judge, While AdvaMedDx Seeks Tweaks To VALID Act
FDA Passes The Buck On LDTs, But Floats Ideas





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