Medtech Insight 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 Seek Input On Dx Regs, With Lab-Developed Tests In Focus

This article was originally published in The Gray Sheet

Executive Summary

The House Energy and Commerce Committee is seeking feedback on legislative initiatives Congress should enact in 2015 regarding regulation of diagnostics, and in particular in response to FDA's plan to regulate laboratory developed tests.

You may also be interested in...



Industry Wants More Details On Obama’s Precision Medicine Initiative

The president announced a new plan before Congress that could bolster federal funding for diagnostics and personalized medicine. Industry commended the administration’s move but was also cautious due to the lack of detail and says it wants to be at the drawing table when specifics are put to paper.

FDA Will Face Reforms, Oversight In Republican Congress, Analysts Say

Election gains by Republicans will embolden Congress to put FDA in its oversight “crosshairs,” as members of key Senate and House panels scrutinize how the agency is using its resources. Reforms could also come soon as part of the ongoing 21st Century Cures initiative.

Will Lab-Developed Test Makers Be Subject To Device Tax? It Depends, Shuren Suggests At Hearing

Lawmakers at a Sept. 9 House Energy and Commerce Subcommittee raised questions on whether FDA’s plans to regulate lab developed tests will also make labs subject to the device excise tax.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT033577

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