Navigation Links
PreMD Provides Update on FDA Review
Date:4/11/2008

TORONTO, April 11 /PRNewswire-FirstCall/ - Predictive medicine company PreMD Inc. (TSX: PMD; Amex: PME) today announced that the U.S. Food and Drug Administration ("FDA") has upheld their decision regarding the company's appeal of the not substantially equivalent (NSE) letter it received in January 2008 in connection with a premarket submission to expand indication for its skin cholesterol test. In the ruling, the FDA agreed with the company on two of the three issues on appeal, but concluded that the clinical trial data was not sufficient to determine that the product is substantially equivalent to other markers of cardiovascular risk. PreMD submitted the 510(k) notification in 2007 with the data from a clinical study that was based on guidance received from the FDA in 2004.

"Our situation now is strictly in the area of a scientific disagreement. There is a well defined process for a scientific dispute resolution, one of the paths we will be exploring immediately," said Brent Norton, president and CEO of PreMD. "While the agency has agreed with two of the three issues, including the use of CIMT as a clinical endpoint, we are very disappointed with the decision. We continue to believe that our skin cholesterol test is a beneficial product for healthcare providers and patients, as the test adds to our understanding of those at cardiovascular risk."

The Company disagreed with the original decision as expressed in the NSE determination letter and, in response, appealed the decision via a review with FDA officials. A written appeal was submitted to the FDA and a meeting was held on March 21, 2008 between PreMD, several medical experts, regulatory consultants, executives from AstraZeneca Pharmaceuticals LP, and various FDA personnel involved in the review process. PreMD presented expert analysis of the data gathered during clinical trials, in particular that data relating to the use of carotid intima wall thickness (CIMT) is a determinant for those a
'/>"/>

SOURCE PreMD Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. PreMD Reports Fiscal 2007 Results
2. PreMD Inc. Completes Debenture Financing
3. PreMD Inc. Signs Agreement with Cosmetics Conglomerate
4. PreMD Inc. Announces Debenture Financing
5. PreMD Initiates FDA Review Process and Provides Corporate Update
6. PreMD Announces FDA Decision on POC Skin Cholesterol Test
7. PreMD Announces Valuable Data on PREVU(x) LT Life Insurance Product
8. PreMD Inc. Provides Corporate Update
9. PreMD Provides Update on 510(k) Application for PREVU(x) POC
10. Publication Provides a Wake-Up Call For Clinicians Treating Narcolepsy
11. American Media, Inc. Provides Lenders With Updated Information
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... August 21, 2014 AVEC Health ... announce the addition of Kerry Gillespie as Chief ... healthcare management experience, Gillespie brings an extremely robust ... executive management positions with prominent industry leading organizations ... as President of Triad Isotopes, Inc. a private ...
(Date:8/21/2014)... (PRWEB) August 22, 2014 Top10BestSEOHosting.com ... and announces that iPage ( http://www.top10bestseohosting.com/go/iPage/ ) is ... in 2014. , The manager of Top10BestSEOHosting.com ... cheap hosting supplier. Actually, these companies have outperformed ... and customer support. People can get the best ...
(Date:8/21/2014)... Living in a quality residential community ... along with it. A quality Home Owners Association like ... are available. , Simpson Mill Plantation, ... Community Association Management, LLC made a recent investment in ... provide an additional amenity for their neighborhood. , Situated ...
(Date:8/21/2014)... in the coronary arteries of chronic kidney disease patients ... according to a new study in the Journal ... ). Researchers at the Johns Hopkins Bloomberg School of ... commonly used measures of subclinical atherosclerosis in predicting the ... , Approximately 50 percent of all patients with chronic ...
(Date:8/21/2014)... Improv performers from Fun House Theatre ... at Silverado Turtle Creek memory care community in Dallas. ... ranging from ages 10 to 16, delivers a groundbreaking ... set. The troupe's philosophy is that improv is based ... to touch audiences regardless of their circumstance — including ...
Breaking Medicine News(10 mins):Health News:Kerry Gillespie Appointed as Chief Executive Officer of AVEC Health Solutions 2Health News:iPage Reviews Unveiled Online At Top10BestSEOHosting.com 2Health News:Recreation is the Heart of the Community at Simpson Mill Plantation; Chooses American Parks Company™ for New Playground Equipment 2Health News:Recreation is the Heart of the Community at Simpson Mill Plantation; Chooses American Parks Company™ for New Playground Equipment 3Health News:Measuring calcium buildup to predict heart disease in those with chronic kidney disease 2Health News:Unicorn Clearance Improv Troupe Brings Laughter to Residents with Dementia at Silverado Memory Care 2
... triggered by abortion. However critics term it as an ... that 72% of women who terminated their pregnancies were ... the first four years after their pregnancy than women ... indicated that Women who had an abortion were nearly ...
... Research conducted at Melbourne on skin cancer could save thousands ... than 15 per cent of melanoma cancers but caused up ... melanomas. The research shows the pimple-like melanoma is the most ... severe sunburn can cause a nodular melanoma. It appears anywhere ...
... their country has its first known case of SARS. A ... signs of SARS virus. Health officials sent sent lab samples ... the health ministry said analysis had not yet confirmed the ... the Amur region, which has a booming cross-border trade, closed ...
... deadly brain-wasting diseases might be just what the researchers ... Abnormal proteins called the prions resultantly cause a brain-wasting ... encephalopathy, or mad cow disease in humans. The presence ... together. CJD is usually found in large numbers// in ...
... the past this mask has been well tested whenever ... infection. During all the previous instances around the world for example ... danger this mask was used. SARS or severe acute ... mask to use to protect against infection.. ,Hoarding of ...
... two overlapping genes responsible for bipolar disorder. In previous ... This leads to the idea that the genes may ... as manic-depressive illness, is a brain disorder that causes ... energy and elation alternating with longer periods of fatigue ...
Cached Medicine News:Health News:Brain diseases an outcome of cannibalism, 2
(Date:8/21/2014)... 21, 2014  Vermillion, Inc. (NASDAQ: VRML ... and women,s health, has appointed Holly B. Bauzon ... Ms. Bauzon has a proven track record ... for laboratory services companies. She has more than 20 ... where she held the position of Director, Lab Services ...
(Date:8/21/2014)... ANGELES , Aug. 21, 2014 The spinal ... of the human body. Signals carried to and from the ... motor skills and nervous system. Injury or ailment here can ... or with a loss of control over their body. Though ... on a person,s life, there are more options available to ...
(Date:8/21/2014)... Aug. 21, 2014 /CNW/ - The Canadian Epilepsy Alliance (CEA) ... series designed to educate children about the most common neurological ... Medikidz Explain Epilepsy comic series tells a fictional story ... middle school while living with epilepsy. "Despite ... is still so much misinformation and lack of awareness out ...
Breaking Medicine Technology:Vermillion Appoints Holly B. Bauzon as VP of Sales and Managed Markets 2Don't Live in Pain: Four Life Improving Benefits of Back Surgery 2Action Heroes Harness Powers to Educate Children About Epilepsy 2Action Heroes Harness Powers to Educate Children About Epilepsy 3
... Findings from an international,multicenter, randomized, double-blind, placebo-controlled ... treatment of moderate to severe,plaque psoriasis will be ... meeting,of the World Congress of Dermatology, which takes ... Buenos Aires, Argentina. The presentation, entitled CNTO ...
... (Nasdaq: ARNA ) today announced positive preliminary ... in patients with chronic insomnia. APD125,is an orally ... being,evaluated in insomnia patients who have difficulty maintaining ... patients treated with APD125,experienced statistically significant improvements in ...
Cached Medicine Technology:Pivotal Ustekinumab (CNTO 1275) Phase 3 Data to Debut at World Congress of Dermatology Meeting 2Arena Pharmaceuticals Announces Positive Phase 2 Clinical Trial Results of APD125 for the Treatment of Insomnia 2Arena Pharmaceuticals Announces Positive Phase 2 Clinical Trial Results of APD125 for the Treatment of Insomnia 3Arena Pharmaceuticals Announces Positive Phase 2 Clinical Trial Results of APD125 for the Treatment of Insomnia 4Arena Pharmaceuticals Announces Positive Phase 2 Clinical Trial Results of APD125 for the Treatment of Insomnia 5Arena Pharmaceuticals Announces Positive Phase 2 Clinical Trial Results of APD125 for the Treatment of Insomnia 6Arena Pharmaceuticals Announces Positive Phase 2 Clinical Trial Results of APD125 for the Treatment of Insomnia 7
5L...
... A fixed pipette is ... a single volume. Fixed volume ... and advantages as other Finnpipette ... design, Super blow-out (1-40ul), Soft-touch ...
... Family includes fixed-volume, adjustable-volume, and multichannel ... Eppendorf Research pro Pipette. Designed with ... high-performance pipettes have earned a worldwide ... use with original Eppendorf pipette tips, ...
10L...
Medicine Products: