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

Infectious Disease Experts Say Diagnostics Underutilized, More Needed

This article was originally published in The Gray Sheet

Executive Summary

The Infectious Diseases Society of America released a policy paper that “raises the red flag about the paucity of new and rapid tests despite years of promises from the molecular era.” It recommends simplifying regulations and improving the reimbursement process, as well as physician education.

You may also be interested in...



CMS Director To Diagnostics Industry: Prove Your Cancer Tests Work

“Why are insurers so reluctant to get enthusiastic and really embrace molecular diagnostics?” asked the director of CMS’ coverage and analysis group at a recent cancer diagnostics symposium. “Because half the time we have no idea what on earth we’re paying for.”

A “Breakthrough” Reality Check: Sponsors Seek FDA Flexibility On Manufacturing, Diagnostics

FDA’s much-anticipated guidance on expedited programs for drug development fills in some blanks on the new breakthrough designation, but simply advising sponsors they will need to pick up the pace on manufacturing plans and development of companion diagnostics leaves aspiring applicants wanting more, stakeholders said at DIA.

Partisan Politics Returns To US FDA Congressional Oversight

The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT032577

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