Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Lawmakers Press OMB To Release Lab-Developed Test Draft Guidance

This article was originally published in The Pink Sheet Daily

Executive Summary

In a letter to the Office of Management and Budget director, nine Democratic representatives urge the release of a draft guidance establishing an FDA oversight structure for laboratory-developed tests. FDA said more than a year ago that the documents were under administrative review.

You may also be interested in...



Lab-Developed Test Regs In Spotlight With Citizen Petition, Hamburg Speech

The American Clinical Laboratory Association filed a citizen petition with FDA June 4 reiterating and formalizing its long-held opposition to FDA regulating laboratory-developed test services. The petition closely followed a speech from FDA Commissioner Hamburg emphasizing plans to do just that.

FDA Aims To Finalize Framework For Lab-Developed Tests In Near Term

FDA could have a final framework in place for overseeing a greatly expanded range of laboratory test services within months of a public meeting scheduled for July, according to agency officials

Would Expanded Lab-Test Regulation Overstep FDA’s Legal Limits?

Efforts to alter the way laboratory tests are regulated highlight the need to better define FDA's authority over certain medical products

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS076119

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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