Medtech Insight 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


FDA Guidance Addresses Emergency Use Authorization For H1N1 Tests

This article was originally published in The Gray Sheet

Executive Summary

With seven H1N1 diagnostics already authorized for emergency use by FDA, the agency is signaling its interest in promoting additional alternatives with the release of a Nov. 2 guidance document

You may also be interested in...

Gen-Probe H1N1 flu test

FDA grants emergency use authorization for Gen-Probe's Prodesse ProFlu-ST flu test, to be used in high-complexity CLIA labs to diagnose H1N1 influenza, firm announces Oct. 29. The reverse transcription polymerase chain reaction (RT-PCR) test employs an algorithm linked to seasonal influenza A/H1 and A/H3 virus test results. Other H1N1 flu tests granted EUAs in recent months include Quest Diagnostic's Simplexa Influenza A H1N1 (2009) and Focus Diagnostics Influenza H1N1 (2009) tests ("1The Gray Sheet" Oct. 26, 2009)

Big Pharma BD Execs Tell Start-Ups: Don’t Be Afraid To Ask Us For Help

Business development leaders and venture capital investors spoke at Biocom’s annual partnering conference about what they are seeking in relationships with entrepreneurs and start-ups.

Transformation Into Viatris Not Seen As The Solution Mylan Needs

Mylan’s full year 2019 earnings report was its last as an independent company, so the focus was on the coming merger with Pfizer’s Upjohn and growth prospects for the new company, Viatris.





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