Navigation Links
AMP asks FDA to address barriers to device innovation
Date:6/25/2010

Washington, DC (June 25, 2010): Yesterday, the Association for Molecular Pathology (AMP) gave public comments at the FDA's Center for Devices and Radiological Health (CDRH) Council meeting on Medical Device Innovation: Barriers to Market for Molecular Diagnostic Tests.

AMP commends the Federal departments and agencies that compose the Council on Medical Device Innovation for making efforts to identify and remove barriers to innovation and progress in transitioning basic and transitional research findings into routine clinical practice. In its remarks, AMP identified three barriers that impede the path to FDA clearance or approval for diagnostic tests and reduce the motivation to submit some medically useful tests for review.

Barrier 1. The paucity of standard reference materials for all areas of molecular diagnostics, i.e., genetic, oncology, and infectious disease testing, inhibits the production of appropriate control materials and methods. "AMP is eager to see more progress and investments in this area," said Dr. Mark Sobel, AMP's Executive Officer. "FDA can assist by providing a list of needed standard reference materials to relevant organizations such as the National Institute of Standards and Technology (NIST) and World Health Organization (WHO)."

Barrier 2. The difficulty of obtaining rare specimens for studies presents a barrier to submission of applications for the approval of new indications for currently approved tests. Herpes Simplex Virus (HSV) testing has been the standard of care for the diagnosis of central nervous system (CNS) disease (HSV encephalitis and meningitis) for over a decade, yet an FDA approved test does not yet exist. HSV CNS infections are relatively rare and any individual laboratory may receive only 1-2 HSV encephalitis positive specimens a year. Manufacturers who developed assays for the novel 2009 influenza H1N1 strain encountered similar difficulties in validating their assays using prospect
'/>"/>

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

Page: 1 2 3

Related medicine news :

1. National Oncologist Group Warns: Current Health Care Reform Legislation Woefully Short In Addressing Cancer Care Crisis
2. National Oncologist Group Warns: Current Health Care Reform Legislation Woefully Short in Addressing Cancer Care Crisis
3. Statement From American Heart Association CEO Nancy Brown on President Obamas State of the Union Address
4. Statement From the American Health Care Association and National Center for Assisted Living in Anticipation of President Obamas State of the Union Address
5. Props for the President at His State of the Union Address
6. Greenfaith Ministry Calls on Churches & Doctors, to Address all Cannabis Issues and Regulation
7. HealthWyse Clinical and Financial Point of Care Software Addresses OASIS-C Regulations and More
8. New England Journal of Medicine Perspective by Irwin Redlener, MD, Addresses Health Care Reform
9. Aging Expert's New Book Helps Boomers Address Challenges of Caregiving
10. Abortion Compromise Does Not Address Core Problem In Senate Health Bill, Says Cardinal DiNardo, Bishops Pro-Life Chair
11. Study Finds Family Members Play Critical Role in Addressing Loved Ones' Hearing Loss
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/25/2014)... October 25, 2014 The ... which verifies IT-accessibility for disabled users by disabled ... logo to Mackin Educational Resources of Burnsville, ... management system and to the Minnesota Alliance for ... "Own Best Medicine" website. Both organizations ...
(Date:10/25/2014)... October 25, 2014 Homeowners that are ... ‘gone bad’ need wonder no more. Clean Crawls ... should watch out for when it comes to insulation ... to the article released by Clean Crawls, can cause ... that any insulation that has deteriorated, become damp, or ...
(Date:10/25/2014)... Limbkeepers® announced today that they will be featured ... Jr, airing 1st QTR 2015 via Discovery Channel. Dates ... will focus on Limbkeepers® non compression knit sleeves, a ... arms, hands, and legs from abrasion, skin tears and ... help reduce injuries, allow for continued daily activities, and ...
(Date:10/25/2014)... 24, 2014 (HealthDay News) -- Not getting the right ... colitis, a new study suggests. Those who sleep ... hours per night may be more prone to developing ... researchers report. The study authors concluded that duration and ... among patients with inflammatory bowel diseases. "Both short ...
(Date:10/25/2014)... Oct. 23, 2014 (HealthDay News) -- Current osteoporosis ... younger postmenopausal women at risk for osteoporosis-related fractures, ... to prevent fractures, we need tools that help ... injuries so that we can target these at-risk ... Crandall, professor of medicine in the division of ...
Breaking Medicine News(10 mins):Health News:IT-Accessibility Award Granted to Education and Health Care for Section 508/WCAG 2Health News:IT-Accessibility Award Granted to Education and Health Care for Section 508/WCAG 3Health News:5 Signs Indicating That Insulation Needs Replacing as Told By Clean Crawls in Recent Article 2Health News:Upcoming Episode of Innovations with Ed Begley, Jr. to Feature Limbkeepers® 2Health News:Sleep Duration Linked to Ulcerative Colitis Risk in Study 2Health News:Osteoporosis Screening Guidelines May Miss Younger Women at Risk 2
... thing in medical research from the field of orthopedics is the use of ... to be true but read on to know more. , ... broken, and you have a cast and you are asked to wait for ... Imagine the amount of trauma and agony you would go through!// ...
... Ohio, the United States of America, have transplanted a bovine jugular ... due to a weakened valve of a vein in his right ... in man to treat varicose ulcers. , ... at Toledo, Ohio, are ecstatic that the procedure has succeeded very ...
... be round the corner as scientists have traced the pathway of ... with they have experimented on the rat brain and they are ... that such advances have been made vis-à-vis eating disorders. ... brain cells respond to hormones, among them two proteins called leptin ...
... scientists have created mice with unusually long memories raising hopes ... of helping people forget their distressing past. “This study has ... govern memory and learning in the brain,” said Isabelle Mansuy, ... , This breakthrough provides ...
... A herpes virus that causes infectious mononucleosis, Epstein-Barr virus (EBV), ... Hodgkin's disease. But no one has carefully studied the possible ... by Dr. Christina A. Clarke from Northern California Cancer Center ... This virus is believed to increase the risk for ...
... and wound healing has always been difficult terrain for scientists ... and understanding inter cellular mechanisms is the key to knowing ... Researchers led by Vito Quaranta at The ... protein that helps trigger the healing process -- also tells ...
Cached Medicine News:Health News:Scientists use plastic to help body make new bone!!!! 2
(Date:10/22/2014)... N.J. , Oct. 22, 2014  Quest Diagnostics ... of diagnostic information services, today announced that its Board ... serve as a director, effective December 1, 2014. Including ... Dr. Leiden is the Chairman, President and CEO of ... years of scientific and commercial experience in the pharmaceutical ...
(Date:10/22/2014)... -- Charlene Vernak, RPh, of Vernak Farms Pharmacy in ... the George Roentsch Scholarship by the Professional Compounding Centers ... Houston during PCCA,s International Seminar, held ... an independent pharmacist and PCCA member who embodies the ... a well-known pharmacist in the compounding community. ...
(Date:10/22/2014)... 22, 2014  Paper Pak Industries, a manufacturer ... ® Body Guard Bio, a disposable, highly ... bacteria and virus while protecting service providers and ... features a rugged, external nylon shell, watertight zipper, ... leak-proof inner chamber that contains contaminated and potentially ...
Breaking Medicine Technology:Quest Diagnostics Adds Jeffrey M. Leiden, M.D., Ph.D., to Board of Directors 2Quest Diagnostics Adds Jeffrey M. Leiden, M.D., Ph.D., to Board of Directors 3PCCA Awards Charlene Vernak, RPh, the George Roentsch Scholarship 2New, State-Of-The-Art Body Bag Minimizes The Spread Of Bacteria And Virus 2
... NEW YORK, March 16, 2011 Reportlinker.com announces ... in its catalogue: Global Temperature ... This report analyzes the worldwide ... by the following Product Segments: Digital Thermometers, Infrared ...
... Reportlinker.com announces that a new market research ... Global Analgesics Industry ... the worldwide markets for Analgesics in US$ Million ... Ibuprofen, and Others (includes combination drugs)), and External ...
Cached Medicine Technology:Global Temperature Monitoring Devices Industry 2Global Temperature Monitoring Devices Industry 3Global Temperature Monitoring Devices Industry 4Global Temperature Monitoring Devices Industry 5Global Temperature Monitoring Devices Industry 6Global Temperature Monitoring Devices Industry 7Global Temperature Monitoring Devices Industry 8Global Temperature Monitoring Devices Industry 9Global Temperature Monitoring Devices Industry 10Global Temperature Monitoring Devices Industry 11Global Temperature Monitoring Devices Industry 12Global Temperature Monitoring Devices Industry 13Global Temperature Monitoring Devices Industry 14Global Temperature Monitoring Devices Industry 15Global Temperature Monitoring Devices Industry 16Global Temperature Monitoring Devices Industry 17Global Temperature Monitoring Devices Industry 18Global Analgesics Industry 2Global Analgesics Industry 3Global Analgesics Industry 4Global Analgesics Industry 5Global Analgesics Industry 6Global Analgesics Industry 7Global Analgesics Industry 8Global Analgesics Industry 9Global Analgesics Industry 10Global Analgesics Industry 11Global Analgesics Industry 12Global Analgesics Industry 13Global Analgesics Industry 14Global Analgesics Industry 15Global Analgesics Industry 16Global Analgesics Industry 17Global Analgesics Industry 18Global Analgesics Industry 19
BatCup cotyloid implant, designed for use in revision surgery, is an hemispherical metal cup, with grooves on the edges that house locking flanges, which are attached to the iliac bone by cancellous ...
... Metal material and modularity into ... a fusion of technology and versatility ... for initial and long-term stability, but ... shell and liner options to address ...
The cementless biomEx cup can be used with both cemented and cementless femoral stems....
The Trilogy system builds on the success of the Harris/Galante Porous and HGP II cups by combining proven features with new technology designed to inhibit the formation and migration of polyethylene ...
Medicine Products: