Navigation Links
PreMD Initiates FDA Review Process and Provides Corporate Update
Date:2/12/2008

TORONTO, Feb. 12 /PRNewswire-FirstCall/ - Predictive medicine company PreMD Inc. (TSX: PMD; Amex: PME) today provided an update on the company's business direction in light of the recent decision from the U.S. Food and Drug Administration (FDA).

Appeal to the FDA

PreMD today filed a request for a second level review of the 510(k) submission, in accordance with the following Code of Federal Regulations 21 CFR part 10.75(c). As announced on Jan. 15, the company received a non-substantially equivalent (NSE) letter from the FDA regarding the 510(k) submission for an expanded regulatory claim on its point-of-care (POC) skin cholesterol test. PreMD continues to believe that its skin cholesterol test merits 510(k) clearance. "We have acted as quickly as possible in initiating the process and will continue to evaluate the best strategies to help achieve FDA clearance," said Brent Norton, president and chief executive officer of PreMD. PreMD is working with AstraZeneca Pharmaceuticals, which has licensed the test for marketing and distribution in the United States, to fully explore the issues raised by the FDA and address the appropriate steps going forward.

Additional Company Information

In light of PreMD's financial status, the company also has taken actions to maximize company value. These actions include a workforce reduction of approximately 33% and other general and administrative expense decreases. The key members of PreMD are concentrating their efforts on the FDA review and assessing strategic alternatives to maximize shareholder value. PreMD will continue to realign its organization and optimize the company's cost structure and cash resources. PreMD continues to advance the development programs for other product candidates in its oncology pipeline, which remain unaffected by the FDA decision.

PreMD also recently appointed Ronald Henriksen as Chair of the Audit Committee. Mr. Henriksen has been a director of PreMD since 2004
'/>"/>

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

Page: 1 2 3

Related medicine news :

1. PreMD Provides Update on 510(k) Application for PREVU(x) POC
2. PreMD Inc. Provides Corporate Update
3. PreMD Announces Valuable Data on PREVU(x) LT Life Insurance Product
4. PreMD Announces FDA Decision on POC Skin Cholesterol Test
5. Tyco International Increases Quarterly Dividend 36 Percent to 15 Cents per Share; Initiates New $1 Billion Share Repurchase Program
6. Chemical Diversity Initiates International Prostrate Cancer Discovery Partnership
7. Vista Partners Initiates Coverage on Raptor Pharmaceuticals Corp.
8. GenPrime Initiates External Clinical Trials of its Bacterial Contamination Test for Rapid Detection of Bacteria in Platelets
9. U.S. Oncology Initiates Complete Phase Ib Trial of Brostallicin Combination Therapy in Advanced Solid Tumors
10. Harbinger Research Initiates Coverage on HearAtLast
11. Wyeth Consumer Healthcare Initiates Voluntary Recall and Replacement Program for Several Robitussin Products and Childrens Dimetapp Cold & Chest Congestion
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/17/2014)... gas prices rose in recent years, so did motorcyclist ... times of gas increases, more people start using motorcycles ... explained. They examined data gathered between 2002 and ... motorcycle registrations in the United States and the third ... a strong association between rising gas prices and an ...
(Date:12/17/2014)... News) -- Greater participation in music classes may benefit ... followed kids in the nonprofit Harmony Project, which provides ... Angeles. Over two years, children who actively participated ... brain processes speech and reading, compared to those with ... active participation in music classes occurred in the same ...
(Date:12/15/2014)... 2014 A recent survey found that ... as impacting skin health and beauty were: “Connections,” “climate,” ... care.” Water and health advocate and radio host Sharon ... describing the survey and the Four C’s.* Kleyne notes, ... category discussed would benefit from paying attention to one’s ...
(Date:12/15/2014)... Beach, FL (PRWEB) December 15, 2014 South ... , knows that holidays can be a daze of hassle, ... slips and falls while decking halls, to burns when making ... of holiday hazards that can happen at any time. To ... pain, MD Now has made a list of helpful and ...
(Date:12/15/2014)... Steven Reinberg HealthDay Reporter ... study should reassure the millions of American women who have ... cancer. "There is no association between migraine and breast ... of medicine at Harvard Medical School. "There is no positive ... is no protective effect either." About 18 percent of ...
Breaking Medicine News(10 mins):Health News:When Gas Prices Go Up, So Do Motorcycle Accidents, Study Finds 2Health News:Music Classes Boost Language Skills, Study Says 2Health News:Water and health advocate Sharon Kleyne adds a “W” for fresh water to “four C’s of skin care” 2Health News:Water and health advocate Sharon Kleyne adds a “W” for fresh water to “four C’s of skin care” 3Health News:MD Now Urgent Care Presents Healthy Holiday Tips 2Health News:MD Now Urgent Care Presents Healthy Holiday Tips 3Health News: No Link Between Migraine, Breast Cancer Risk, Study Says 2
... ... Asks What’s Next for Doctors under New Healthcare Reform Bill, , ... Dallas, TX (Vocus) April 19, 2010 – The recent ... ’ ( Brown Books ) addresses how the health care system has been hostage for ...
... ... ... 18, 2010 -- This weekend, more than 30,000 attendees at the International Cannabis & ... to the nation’s first retail branded, complete medical marijuana product line. , , ,YAK ...
... to help with care, researchers say , SUNDAY, April 18 ... ill older people in the United States live alone, a ... to take care of their parents and relatives, a new ... significantly help many patients with chronic illness manage their health ...
... ... North East Alabama, has successfully completed deployment of CellTrak workflow automation and visit compliance ... HR payroll. , ... Schaumburg, IL (PRWEB) April 18, 2010 -- ABC Hospice, Inc, a premier hospice provider ...
... ... Washington, hits the big time , ... Oak Harbor, WA (PRWEB) April 19, 2010 -- In the highly-competitive natural skincare industry, ... Tacia, Oak Harbor resident and owner of Bella Vé Natural Skin Care, has recently launched ...
... faster times as the goal, while females hope to ... -- Women run marathons to feel good while men run ... suggests. , The research included 507 female and 399 male ... questionnaire designed to reveal the participants, motivation for taking part ...
Cached Medicine News:Health News:Recent Book Moves Beyond Defensive Medicine, Tackles Entitlement Reform 2Health News:Recent Book Moves Beyond Defensive Medicine, Tackles Entitlement Reform 3Health News:First Retail Branded Edible Medical Marijuana Product Line Introduced at San Francisco Trade Show 2Health News:First Retail Branded Edible Medical Marijuana Product Line Introduced at San Francisco Trade Show 3Health News:First Retail Branded Edible Medical Marijuana Product Line Introduced at San Francisco Trade Show 4Health News:1 in 4 Chronically Ill Elderly Lives Alone 2Health News:CellTrak Increases Employee Productivity and Efficiencies at ABC Hospice, Inc. 2Health News:CellTrak Increases Employee Productivity and Efficiencies at ABC Hospice, Inc. 3Health News:Hollywood Eco-Celebrity Rachelle Carson-Begley Gives Skincare Company Bella V Rave Reviews 2Health News:Hollywood Eco-Celebrity Rachelle Carson-Begley Gives Skincare Company Bella V Rave Reviews 3Health News:Hollywood Eco-Celebrity Rachelle Carson-Begley Gives Skincare Company Bella V Rave Reviews 4Health News:Are Male Marathoners More Competitive Than Women? 2
(Date:12/17/2014)... -- Strategic Health Services, Inc. (SHS), a leading provider of ... agreement with QualCare, Inc., a leading provider of health plans ... marketplace.  This agreement will further QualCare,s population health management ... brings to its clients in New Jersey ... QualCare plans cover more than 800,000 member lives, with ...
(Date:12/17/2014)... December 17, 2014 , ... than a hub of information concerning the biopharmaceutical Group,s national ... A further addition to the recently launched institutional website that ... now been enriched by a new chapter in the fascinating ... A richly detailed and panoramic hub on the world of ...
(Date:12/17/2014)... RALEIGH, N.C. , Dec. 17, 2014 ... and Integrated Clinical Trial Services, LLC (ICTS), two ... clinical trials announce that they have formed a ... (i-CTMS). i-CTMS will provide a broad range of ... and medical device companies. i-CTMS will ...
Breaking Medicine Technology:Strategic Health Services to collaborate with QualCare on Population Health and Wellness Technology for QualCare Members 2Strategic Health Services to collaborate with QualCare on Population Health and Wellness Technology for QualCare Members 3Dompé Offers a New "Window" on the World of Scientific Research, with the http://www.dompetrials.com Website, Dedicated to Clinical Trials 2Dompé Offers a New "Window" on the World of Scientific Research, with the http://www.dompetrials.com Website, Dedicated to Clinical Trials 3Integrated Clinical Trial Services and Clinical Trial Marketing Communications Form Joint Venture 2Integrated Clinical Trial Services and Clinical Trial Marketing Communications Form Joint Venture 3
... IDM Pharma, Inc.,(Nasdaq: IDMI ) today ... for Medicinal Products for Human Use (CHMP) and ... 25th, following the,CHMP,s September meeting where CHMP considered ... for the,treatment of patients with non-metastatic, resectable osteosarcoma, ...
... Preventing Possibly Life-Threatening,Condition During Air Travel, ALEXANDRIA, ... (APTA) supports the recent "Call to Action" by,Acting ... reduce the number of,cases of deep vein thrombosis ... According to Susan Scherer, PT, PhD, associate professor ...
Cached Medicine Technology:IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following September Meeting of European Committee for Medicinal Products for Human Use (CHMP) 2IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following September Meeting of European Committee for Medicinal Products for Human Use (CHMP) 3IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following September Meeting of European Committee for Medicinal Products for Human Use (CHMP) 4IDM Pharma Provides Update on Mifamurtide (L-MTP-PE) Regulatory Status Following September Meeting of European Committee for Medicinal Products for Human Use (CHMP) 5APTA Supports Surgeon General's 'Call to Action' to Prevent Deep Vein Thrombosis and Pulmonary Embolism 2APTA Supports Surgeon General's 'Call to Action' to Prevent Deep Vein Thrombosis and Pulmonary Embolism 3
...
...
Ascent Primary Knee System with cruciate retaining, posterior stabilized and constrained components...
Ascent Primary Knee System with cruciate retaining, posterior stabilized and constrained components...
Medicine Products: