Navigation Links
FDA to Revise Herpes Test Rules in the US

The Food and Drug Administration (FDA) of the United States proposes to revise rules that could make herpes virus tests cheaper and more extensively available.//

The FDA said it might change the classification of tests for herpes simplex virus types 1 and 2 to class II from class III, which would reduce the regulatory burdens associated with the tests.

The change would pave the way for companies seeking to develop and market herpes tests, and also relax the training requirements for laboratories and medical offices that offer the tests, an FDA spokesperson said.

The FDA had considered reclassifying the tests as long ago as 1980, but had said the tests posed a "potential unreasonable risk of illness or injury" at the time. With the older tests, a false positive could expose a pregnant mother or her baby to unnecessary treatment with antiviral drugs or lead to an unnecessary Caesarean delivery of the child. A false negative could result in the infection of a newborn infant, which could be fatal.

The FDA says the reliability and performance of the tests has improved now. It has set a deadline of April 10 for comments on the reclassification.

At least 45 million Americans 12 and older have genital herpes, which is generally caused by the type 2 virus, according to the Centers for Disease Control and Prevention.


'"/>




Page: 1

Related medicine news :

1. FDA To Set New Guidelines To Revise Drug Companies Marketing Tactics
2. Revised Pregnancy Counselling Item Still Flawed
3. Royal College Issues Revised Guidelines for Face Transplantation
4. Government Allot More Funds for Revised TB Program
5. Revised Cholesterol Guidelines Causes Concern Among Medical Community
6. Drug Stops Herpes
7. Drug Found To Reduce The Transmission Of Herpes
8. Cancer Causing Herpes Virus At Last May Have A Cure
9. Treating Latent Herpes With Licorice
10. Experts Insist That Neonatal Herpes Be Reported Regularly
11. Protection against HIV and Herpes is possible with the Experimental Microbicide
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding ... of its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. ... James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... recover from injury. Recently, he has implemented orthobiologic procedures as a method for ... is one of the first doctors to perform the treatment. Orthobiologics are substances ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits ... terms of the latter, setting the bar too high can result in disappointment, perhaps ... slow progress toward their goal. , Research from PsychTests.com reveals that ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic ... many turn to unhealthy avenues, such as drug or alcohol abuse, as a coping ... released tools for healthy coping following a traumatic event. , Trauma sufferers tend to ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out ... family verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers ... would throw rocks at my other children and say he was going to kill them. ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... June 24, 2016 Research and Markets ... for Companion Diagnostic Tests" report to their offering. ... Companion Diagnostics The World Market for Companion ... medicine diagnostics. Market analysis in the report includes the following: ... (In Vitro Diagnostic Kits) by Region (N. America, EU, ROW), ...
(Date:6/23/2016)... -- MedSource announced today that it has selected Datatrial,s ... choice.  This latest decision demonstrates MedSource,s commitment to ... by offering a state-of-the-art electronic data capture (EDC) ... the EDC platform of choice in exchange for ... long been a preferred EDC platform by our ...
(Date:6/23/2016)... 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) ... Elecsys BRAHMS PCT (procalcitonin) assay as a dedicated testing ... With this clearance, Roche is the first IVD company ... for sepsis risk assessment and management. PCT ... PCT levels in blood can aid clinicians in assessing ...
Breaking Medicine Technology: