Corporate Social Responsibility | Business Wire | PR NewsWire | Marketwire | Realwire | ACN/JCN newswire | 247pressrelease | PRWeb

FDA Publishes Guidance on Diagnostic Tests for 2009 H1N1 Influenza Virus

Posted : Mon, 02 Nov 2009 20:44:28 GMT
Author : U.S. Food and Drug Administration
Category : Press Release
News Alerts by Email ( click here )
News | Home
SILVER SPRING, Md., Nov. 2 FDA-H1N1-guidance

SILVER SPRING, Md., Nov. 2 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today published a guidance document that should help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic manufacturers can submit a request to the FDA for an Emergency Use Authorization (EUA). If granted, the EUA will allow the test to be used during the national public health emergency declared by Department of Health and Human Services Secretary Kathleen Sebelius in April. This guidance document outlines what information the FDA recommends that manufacturers include in these EUA requests.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

The EUA authority allows the FDA to authorize use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a declaration of emergency, when certain criteria are met. The authorization ends when the declaration of emergency is terminated or the authorization is revoked by the FDA.

The EUA authority is part of Project BioShield, which became law in July 2004.

While the FDA encourages manufacturers to submit appropriate premarket applications for these tests, the agency also recognizes that it may not be possible to generate complete clinical validation data that would normally be included in an application. However, this guidance outlines information the FDA recommends be included, and the FDA gives these requests thorough and careful review to protect the public health.

During this declared public health emergency, manufacturers of 2009 H1N1 influenza virus tests that are unable to submit a complete premarket notification may use the guidance to submit a request for an EUA.

The guidance document is part of the FDA's ongoing efforts to provide public health authorities managing the pandemic with reliable and accessible diagnostic tests. The guidance is available online at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM188679.pdf, and will remain in effect throughout the public health emergency.

For more information:

The FDA's Guidance Document on 2009 H1N1 Influenza Virus Diagnostics
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM188679.pdf
The FDA's Emergency Use Authorization of Medical Products
http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm
The FDA's Emergency Use Authorization Questions and Answers
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm153297.htm

Media Inquiries: Peper Long, 301-796-4671; mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration


Copyright © 2008 PR Newswire. All rights reserved.

Share/Save/Bookmark

Article : FDA Publishes Guidance on Diagnostic Tests for 2009 H1N1 Influenza Virus
Print this article
Share this article

Stay Updated

News gadget on your Google homepage
Subscribe to a news feed in Google Reader



Related News

Much to See and Do in Madera County on Thanksgiving and Holiday Weekend
Numerous options will be available to visitors to California's Gateway to Yosemite who are looking for a bite to eat Thanksgiving. There will also be plenty to see and do throughout the weekend wineries, Christmas Tree lightings and more./I/P PMadera County, CA (Vocus) November 23, 2009...

EXAM-PACS® for iPhone, EXAM-PACS for Mac and EXAM-PACS for Windows 7—We’ve Got Your PACS at RSNA 2009
RIDGEFIELD, Conn. - Highlighted by a revolutionary new touch-screen viewing system for the popular Apple iPhone, CoActiv (Booth 7544) introduces an EXAM-PACS platform for every user preference at RSNA 2009--including Windows 7, Mac OS X with the current OsiriX DICOM viewer and the new OsiriX

Winning Vinny Named in New York-New York Spokesperson Competition
LAS VEGAS, NV -- 11/23/09 -- MGM MIRAGE (NYSE: MGM) -- Today, New York-New York Hotel & Casino announced the winner of the Vinny vs. Vinny spokesperson competition. After weeks of spirited challenges, New York-New York's guests, through voting..

Vietin Bank Starts Merchant Acquiring for JCB Card in Vietnam
Tokyo, Nov 24, 2009 - (JCN Newswire) - JCB International Co., Ltd., the international operations subsidiary of JCB, the only international payment brand from Japan, announced that Vietnam Joint Stock Commercial Bank for Industry and Trade (Vietin Bank), one of the larges...

OKI Uses "DressUP CockPit V3" to Reduce Cost of Monitoring Its Group's Core System by 80 Per Cent
TOKYO - OKI Electric Industry (TOKYO:6703) today announced it has

Research and Markets: Malaysia Retail Report Q1 2010 Reveals Total Retail Sales to Grow From an Estimated US$33bn in 2009 to More than US$61bn by 2014
DUBLIN - Research and Markets (

Newmont and Sumitomo Enter into an Agreement to Sell an Additional 14% Share Sale of PTNNT for $494 Million
DENVER, Nov. 23 -- Newmont Mining Corporation (NYSE: NEM) ("Newmont" or the "Company") today announced that its subsidiary, Newmont Indonesia Limited, together with Nusa Tenggara Mining Corporation ("NTMC") (an affiliate of Sumitomo C...

Have your Say
Name
Email
Subject
Your Comment

Enter Verification code
 
  

 
Follow The Earth Times
Subscribe to RSS Follow Earth Times on TwitterNews by email
Share/Save/Bookmark
 
 



 
Subscribe to free Earthtimes
News Alerts by Email Click here
For RSS Feeds Click here
or Create your own RSS

Add to Google Toolbar
Breaking News
Press Releases

 


The Earth Times
News Category

© 2009 www.earthtimes.org, The Earth Times, All Rights Reserved | Privacy Policy
Earth Times accept no responsibility or liability either directly or indirectly for views or opinions expressed in articles or comments.