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:6/26/2016)... , ... June 26, 2016 , ... PawPaws brand ... new product that was developed to enhance the health of felines. The formula is ... The two main herbs in the PawPaws Cat Kidney Support Supplement Soft ...
(Date:6/25/2016)... ... , ... The temporary closing of Bruton Memorial Library on June 21 due to a possible ... often overlooked aspect of head lice: the parasite’s ability to live away from a human ... but a necessary one in the event that lice have simply gotten out of control. ...
(Date:6/25/2016)... ... ... Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health and Mental ... exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards took place ... BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to receive an ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Marcy was in a crisis. Her son James, ... out at his family verbally and physically. , “When something upset him, he couldn’t control ... use it. He would throw rocks at my other children and say he was going ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, ... minimum wage raise to $12 an hour by 2020 and then adjusting it yearly to ... value of the minimum wage, assure the wage floor does not erode again, and make ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... 2016  Astellas today announced the establishment of Astellas Farma Colombia (AFC), a new affiliate with operations headquartered in ... America . ... ... ... ...
(Date:6/23/2016)... , June 23, 2016  Guerbet announced today ... Inc.,s Supplier Horizon Award . One ... Guerbet was recognized for its support of Premier members ... through clinical excellence, and commitment to lower costs. ... receive this recognition of our outstanding customer service from ...
(Date:6/23/2016)... Research and Markets has announced the addition ... States, China, Japan, Brazil, United Kingdom, Germany, France, Italy, ... Surgical Procedure Volumes: Global ... surgical procedure volume data in a geographic context. The ... of growth drivers and inhibitors, including world population growth, ...
Breaking Medicine Technology: