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

US FDA’s Long Wait For Diagnostics Reform Legislation Continues

Executive Summary

FDA is hoping Congress might take up proposed legislation governing the regulation of diagnostic tests produced in laboratories in 2023. That will make it a full decade of stalemate since FDA outlined a framework to address the new reality of personalized medicine.

You may also be interested in...



US FDA Diagnostic Test Regulation Bill Stays On Back Burner

It is clear that the next step in the long-term debate over whether and how the US FDA should regulate lab-developed tests will come from the administration and not Congress. But key legislators are ready to move quickly if they can get enough support.

FDA Reforms Missed By FDORA Could Find Vehicle In Animal Drug User Fee, Pandemic Bills

The usually lower-profile user fee reauthorizations could gain more attention for broader US FDA issues, said Andi Lipstein Fristedt, FDA deputy commissioner for policy, legislation and international affairs.

Diagnostics Reform Out As Congress Reaches Year-End Omnibus Compromise

A measure that would have moved diagnostics regulation under the US Food and Drug Administration has been culled from the year-end omnibus spending package.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS147598

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