Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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


Coming Together On CLIA Waivers? Industry Hopes To Recruit Patients, Providers To Push Reform

This article was originally published in The Pink Sheet Daily

Executive Summary

Diagnostic firms formed the Coalition for CLIA Waiver Reform last month with the goal of enlisting patients, labs and physicians in the fight to turn back what they say are unreasonable FDA standards for a test to gain access to the broader market of “waived” labs.

You may also be interested in...

FDA Says Final CLIA Waiver Guidance Eases Burdens; Industry Isn’t Satisfied

Final guidelines to companies developing point-of-care diagnostic tests for use in less sophisticated laboratories offer more leeway in clinical trial design than FDA initially proposed

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

FDA Eyes Upclassification, Labeling Guidance To Address Stapler Risks

The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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