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

FDA’s Accelerated Review Of Flu Test Offers A Model For Future Products

This article was originally published in The Gray Sheet

Executive Summary

FDA's rapid review of a laboratory test that can aid in the diagnosis of avian influenza demonstrates a pathway that could be used for the introduction of other much-needed diagnostics, the agency suggests

You may also be interested in...



FDA Recommends Additional Warning On Avian Flu Test Labels

An FDA guidance document advises that language be added to labels of tests for detecting influenza A, or avian flu, stating that negative results should be confirmed with a cell culture

FDA Recommends Additional Warning On Avian Flu Test Labels

An FDA guidance document advises that language be added to labels of tests for detecting influenza A, or avian flu, stating that negative results should be confirmed with a cell culture

Device Companies Awaiting Feedback On Pandemic Stockpile Demand

Some medical device firms are holding out for more specific guidance from the federal government about pandemic flu planning before making firm production plans with products that could play a role in emergency preparedness

Related Content

Latest Headlines
See All
UsernamePublicRestriction

Register

MT023182

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