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

CLIAC Waiver Criteria Input Readied As FDA Gears Up To Draft Guidance

This article was originally published in The Gray Sheet

Executive Summary

The Clinical Laboratory Improvement Advisory Committee is close to issuing waiver recommendations, after agreeing to largely adopt criteria developed by its CLIA waiver workgroup

You may also be interested in...



Long-Awaited CLIA Draft Guidance Offers Some Leeway For Study Design

FDA's CLIA waiver application draft guidance could offer test sponsors added flexibility in designing clinical studies

Long-Awaited CLIA Draft Guidance Offers Some Leeway For Study Design

FDA's CLIA waiver application draft guidance could offer test sponsors added flexibility in designing clinical studies

CLIA-Waived Test Market Increasing As Public Health Concerns Loom

Rapid growth in the adoption of CLIA-waived laboratory tests is causing some unease regarding appropriate use of the tests

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

MT019789

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