Navigation Links
AMP releases statement on diagnostics in drug labels
Date:5/16/2011

o sell its test exclusively to one laboratory, all specimens would have to be shipped to that laboratory for testing even if the source laboratory has access to a different FDA approved or cleared test for the same analyte. Dr. Lyon expressed AMP's concern, "this would drastically increase healthcare costs and over-complicate the laboratory environment. And our greatest concern is that it could result in restricting the patient's access to one specific test, which may create additional burdens to the patient including the collection of subsequent samples, increased out-of-pocket costs, and delayed treatment."

AMP hopes that this new position statement will encourage pharmaceutical companies to reference diagnostic tests based on its molecular description and the FDA to work with industry to reinforce the appropriate labeling of its products.

AMP's specific recommendations include:

  • To promote patient safety and high quality care, AMP recommends that FDA specify that diagnostics be described by the biological description of the gene or mutation in drug labeling and that identification of recommended diagnostic testing not be by brand name. Essential performance characteristics (e.g. limit of detection) can be specified. Standardized HUGO nomenclature should be used.

  • AMP notes that The Clinical Laboratory Standards Institute (CLSI) avoids identifying products by brand name in their Guidelines.

  • Identification of diagnostic tests by brand name in drug labeling is only appropriate in the description of relevant clinical studies; AMP recommends that in the remainder of the label, pharmaceutical manufacturers reference the biological description.


'/>"/>

Contact: Mary Williams
mwilliams@amp.org
301-634-7921
Association for Molecular Pathology
Source:Eurekalert

Page: 1 2

Related medicine news :

1. IADR/AADR Journal of Dental Research releases studies on oral health inequalities in older people
2. TBI Therapy and Nutrition: IOM report releases April 20
3. Physics story tops EurekAlert!s 2010 list of most-visited releases
4. California Health Interview Survey releases newest data on state residents health
5. IADR/AADR Journal of Dental Research releases large studies on osteonecrosis of the jaw
6. National committee releases findings on transforming and improving the nursing profession
7. Womens health research: IOM releases progress report Sept. 23
8. Research!America releases vaccines fact sheet
9. MedPage Today Releases Free App for Android Phones
10. Bellaboo Releases One Girl At A Time Documentary
11. Purity Products Releases Alpha 3C
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/28/2015)... 28, 2015 The Classic Denture ... a new special. Throughout all of March patients ... , This service can help overall mouth ... pain. Patients may notice certain symptoms that suggest the ... These symptoms include: , 1.    Pain, clicking, and popping in ...
(Date:2/28/2015)... CA (PRWEB) February 28, 2015 A ... a promising new gene therapy procedure for the treatment ... blindness in patients. Authored by Dr. Robert ... and published in the Lancet Medical Journal on January ... from choroideremia, a rare genetic disorder that mostly affects ...
(Date:2/28/2015)... Pismo Beach, CA (PRWEB) February 28, 2015 ... the needs of Central Coast area residents, recently announced ... Whitening System. It’s a treatment option for new ... patients kick off 2015 with a bright, white smile, ... the discounted price of $299, marked down from the ...
(Date:2/28/2015)... 28, 2015 On Thursday, February 26th, Forbes ... Easy For Scammers To Steal Your Data , which stresses ... hands on a DIY phishing kit, or any kind of ... on another important point about how everyone’s cyber security is ... implemented, “like compromising legitimate content management systems or blogs in ...
(Date:2/28/2015)... ” was featured on NewsWatch as part of its monthly ... coolest technology products and services available to consumers. Scott Steinberg, ... the review and shared with viewers how they provide a ... low battery and no way to charge a phone or ... basis. Even when a person does have a charger, sitting ...
Breaking Medicine News(10 mins):Health News:Classic Denture Center in Portland Oregon is Offering March Discount 2Health News:New Gene Therapy Procedure Could Hold Key to Preventing Blindness for Certain Patients 2Health News:Pismo Beach Dentist Announces Special for Zoom! Teeth Whitening 2Health News:DIY Phishing and Malware Kits Make it Easy to Compromise Businesses in More Ways than One 2Health News:DIY Phishing and Malware Kits Make it Easy to Compromise Businesses in More Ways than One 3Health News:DIY Phishing and Malware Kits Make it Easy to Compromise Businesses in More Ways than One 4Health News:Solutions to Keep Phones Charged were Featured on NewsWatch Television on January 29, 2015 2
... ... Not Flower Club ("FMN-FC") today announced the launch of its online floral gift program, ... well as other diseases associated with aging. , ... Camarillo, California (PRWEB) October 30, 2009 -- In recognition ...
... a monster have sparked new treatments, , FRIDAY, Oct. 30 ... Scary as they are, some of the creepiest, deadliest creatures ... new ways to heal. , , Consider the venom of ... physiology professor at the University of Wisconsin Medical School in ...
... Ill., Oct. 30 First Choice Health Services, Inc. today ... Elite , a compilation of the top-performing home health agencies ... 25 percent of agencies and further highlights the top 100 ... analysis of performance measures in quality outcomes, quality improvement, and ...
... ... one of the very best treatment facilities in the United States. Celebrate A New Life ... one,s own dignity and self-worth, in a comfortable, safe, ocean environment. , ... San Juan Capistano, California (PRWEB) October 30, 2009 ...
... People ... , ... -- With the recent explosion in applications for Social Security disability benefits, people with ... representation, according to Allsup . The Belleville, Ill., company represents tens of thousands ...
... In two new studies, presented at the American ... San Diego, researchers explored the connection between high stress, ... studies, performed by the United States Navy and the ... long term effects of infectious gastroenteritis (IGE) among active ...
Cached Medicine News:Health News:Forget-Me-Not-Flower-Club Launches Floral Gift Program For Caregivers: Alzheimer's Awareness Month Program Offers Resources, Recognition for Friends and Family 2Health News:Forget-Me-Not-Flower-Club Launches Floral Gift Program For Caregivers: Alzheimer's Awareness Month Program Offers Resources, Recognition for Friends and Family 3Health News:Science Finds Healing in Halloween Horrors 2Health News:Science Finds Healing in Halloween Horrors 3Health News:First Choice Health Services, Inc. Named to 2009 HomeCare Elite as a Top Home Health Care Provider 2Health News:First Choice Health Services, Inc. Named to 2009 HomeCare Elite as a Top Home Health Care Provider 3Health News:Celebrate A New Life, Christian Drug Rehab Program, Major Expansion in Southern California 2Health News:Celebrate A New Life, Christian Drug Rehab Program, Major Expansion in Southern California 3Health News:Increasing SSDI Applications Highlight Risk of Applying Without Professional Help, Says Allsup 2Health News:Increasing SSDI Applications Highlight Risk of Applying Without Professional Help, Says Allsup 3Health News:Increasing SSDI Applications Highlight Risk of Applying Without Professional Help, Says Allsup 4Health News:New studies explore connection between high stress jobs and GI disorders 2Health News:New studies explore connection between high stress jobs and GI disorders 3
(Date:2/27/2015)... 2015 WuXi PharmaTech (Cayman) Inc. (NYSE:  WX), ... serving the pharmaceutical, biotechnology, and medical device industries with ... the United States , congratulates our partner ... U.S. FDA for ibalizumab (TMB355). The FDA designates a ... alone or in combination with one or more other ...
(Date:2/27/2015)... , Feb. 27, 2015  Acsis Inc., the ... serialization solutions, announced today that John DiPalo , ... Supply & Demand Chain Executive 2015 Provider ... who are leading initiatives to help prepare their companies, ... today,s business climate. This year,s list of Provider Pros ...
(Date:2/27/2015)... , Feb. 27, 2015 Securities lawyers ... board of Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP ... per share. Concerned SLXP investors are encouraged to contact ... The investigation focuses upon the shareholder value ... Salix shareholders would receive only $158.00 per share in ...
Breaking Medicine Technology:WuXi Congratulates TaiMed Biologics on Receiving Breakthrough Therapy Designation from U.S. FDA 2Acsis CSO John DiPalo Named Supply & Demand Chain Executive 2015 Pro to Know 2
... Calif., Nov. 15, 2010 diaDexus, Inc. (OTC Bulletin Board: ... development and commercialization of patent-protected in vitro diagnostic ... results for the third quarter of 2010. Total revenues for ... growth over total revenues of $2.5 million for the third ...
... SPRING, Md., Nov. 15, 2010 The U.S. ... aimed at facilitating the development of safer, more ... rhythms through improved design and manufacturing practices. ... (Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO ) External ...
Cached Medicine Technology:diaDexus, Inc. Reports 2010 Third Quarter Financial Results 2diaDexus, Inc. Reports 2010 Third Quarter Financial Results 3diaDexus, Inc. Reports 2010 Third Quarter Financial Results 4diaDexus, Inc. Reports 2010 Third Quarter Financial Results 5FDA Launches Initiative to Develop Innovative External Defibrillators 2FDA Launches Initiative to Develop Innovative External Defibrillators 3
Curved Shaft with 5mm Platform; 1x2, 0.12 mm teeth; In Titanium....
0.5mm 1X2 Teeth with 6mm Tying Platform; in Stainless Steel 125...
... 226 trial lenses with polished metal rims ... Concave Lenses: 0.12 to 20.00 Diopters (0.25D ... to 20.00 Diopters (0.25D increments), ,34 Cylindrical ... increments), ,34 Cylindrical Convex Lenses: 0.12 to ...
... Master is designed and constructed ... service and give the professional ... procedures. It embodies the characteristics ... most, including accuracy, speed, ease, ...
Medicine Products: