HiSoftware unveils Web manager (The Nashua Telegraph)
NASHUA HiSoftware released Compliance Sheriff, a hosted management solution that provides testing and reporting for standards-based policies including accessibility and privacy. ...

FDA Rewards Many Figures in Utah Medical Case (Medical Device Link)
In the year leading up to FDA s defeat in Utah federal court in the Utah Medical Products QSR/GMP case, all but two of the agency employees most closely associated with it received bonuses for what the agency characterized as excellent service.

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US FDA seeks more data for Novartis diabetes treatment (New Ratings)
LONDON, February 26 (newratings.com) The US Food & Drug Administration (FDA) has issued an approvable letter for Swiss drug giant Novartis AG s ( NOT.FSE ) Galvus drug for the treatment of type II diabetes, seeking additional data related to the drug.

Alpharma Reports Fourth Quarter 2006 EPS from Continuing Operations of $0.34 (PR Newswire via Yahoo! Finance)
Alpharma Inc. , a global specialty pharmaceutical company, announced fourth quarter 2006 diluted earnings per share from continuing operations of $0.34.

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Update on Salmonella Outbreak and Peter Pan Peanut Butter and Great Value Peanut Butter
On February 14, 2007, FDA advised consumers not to eat any Peter Pan peanut butter purchased since May 2006 and not to eat Great Value peanut butter with a product code beginning with "2111" purchased since May 2006 because of risk of contamination with Salmonella Tennessee.

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Ortec Initiates Premarket Approval (PMA) Application Filing Seeking Approval for OrCel(R) in Treating Venous Leg Ulcers (RedNova)
Ortec International, Inc. (OTCBB: OTCI), a comp

Foolish Forecast: Getting Indigestion with ViroPharma (The Motley Fool)
Views you can use to get clues on tomorrow's news.

FDA still under fire (Nutraingredients.com)
2/23/2007 - The US Food and Drug Administration (FDA) has been coming under increased scrutiny over its approval process and funding mechanism. Later this year, Congress will consider whether to allow the FDA to continue to collect fees from pharmaceutical companies to help pay for the drug approval process.

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FDA Approves Orlistat for Over-the-Counter Use
The Food and Drug Administration (FDA) today approved orlistat capsules as an over-the-counter (OTC) weight loss aid for overweight adults.

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Global Med Technologies(R), Inc. Reports Record Fourth Quarter and Fiscal Year 2006 Results (SYS-CON Media)
Global Med Technologies(R), Inc. ('Global Med' or the 'Company') (BULLETIN BOARD: GLOB) an international e-Health, medical information technology company, reported its financial results for the fourth quarter and year ended December 31, 2006.

Finesse Introduces the TruCell2(TM) Cell Density Sensor (PR Newswire via Yahoo! Finance)
Finesse, LLC, Santa Clara, CA, a manufacturer of measurement and control solutions for life science process applications, announced the general availability of its next generation TruCell2 cell density sensor.

Confirma Advances Computer-Aided-Detection for Breast MRI With Change Control Software From Solidcore (PR Newswire via Yahoo! Finance)
At the Healthcare Information Management Systems Society annual conference, Solidcore Systems, Inc., a leader in change control software for critical systems, today announced that Confirma, the leader in computer-aided-detection for breast MRI, is integrating Solidcore's S3 Control software with the CADstream system.

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FDA Clears First of Its Kind Suture Made Using DNA Technology
FDA announced it has cleared for marketing in the U.S. the TephaFLEX Absorbable Suture the first absorbable polymer suture made from material isolated from bacteria modified by recombinant DNA technology.

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Bruker Optics Expands its FT-IR Product Line with Innovative New Spectrometers (Business Wire via Yahoo! Finance)
CHICAGO----Bruker Optics, exhibiting at Pittcon 2007 booth # 2169, introduces several new innovative FT-IR spectrometers. Bruker Optics manufactured its first Fourier-transform infrared spectrometer in the early 1970s and since then has become well renowned for its commitment to supplying cutting-edge instrumentation with unmatched capabilities.

FDA still under fire (Nutraingredients.com)
2/23/2007 - The US Food and Drug Administration (FDA) has been coming under increased scrutiny over its approval process and funding mechanism. Later this year, Congress will consider whether to allow the FDA to continue to collect fees from pharmaceutical companies to help pay for the drug approval process.

Abraxis BioScience Reports Record Revenue of $765 Million in 2006 Versus $521 Million for 2005 (Business Wire via Yahoo! Finance)
LOS ANGELES----Abraxis BioScience, Inc. , an integrated, global biopharmaceutical company, today reported financial results for the full year and fourth quarter ended December 31, 2006.

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Arista? AH Absorbable Hemostat
Arista ? AH Absorbable Hemostat (Arista AH) is a product that assists the body in clotting blood. After it has performed its function, the body absorbs it. Arista AH is manufactured from potato starch. (Approved: 9/26/2006)

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Americas Kitchen Recalls "Wellsley Farms" Green Bean Casserole Because of Possible Health Risk
Americas Kitchen is recalling its 32-ounce packages of "Wellsley Farms" Green Bean Casserole sold from September 1, 2006 through February 22, 2007 because they have the potential to be contaminated with Listeria monocytogenes.

Media Statement on Voluntary Withdrawal of Giant Eagle Egg Free Pasta Ribbons
Giant Eagle has voluntarily withdrawn all packages (12 oz., UPC 3003404596) of Giant Eagle Egg Free Pasta Ribbons from store shelves in its 227 supermarkets in Pennsylvania, Ohio, West Virginia and Maryland.

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Shire plans to retain few workers in buyout (Roanoke Times)
The news came as the FDA approved the first drug invented by New River Pharmaceuticals. Shire plc, the company that plans to buy New River Pharmaceuticals Inc., intends to close New River's Radford headquarters and Blacksburg research and development division, retaining at best a small number of the company's 46 employees, Shire spokesman Matthew Cabrey said Friday.

Emergent BioSolutions Delivers Approximately 1 Million Doses of BioThrax(R) Ahead of Schedule to U.S. Department of ... (Business Wire via Yahoo! Finance)
ROCKVILLE, Md.----Emergent BioSolutions Inc. announced that yesterday it delivered just under one million doses of BioThrax , the only FDA licensed anthrax vaccine, to the Department of Health and Human Services for placement into the nation's strategic national stockpile .

Theravance Announces FDA Acceptance of Telavancin NDA (Market Wire via Yahoo! Finance)
Theravance, Inc. announced today that the U.S. Food & Drug Administration has accepted the New Drug Application for its investigational antibiotic telavancin for the treatment of complicated skin and skin structure infections caused by Gram-positive organisms, including methicillin-resistant Staphylococcus aureus. The FDA has established a goal of a standard ten-month review of the telavancin ...

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FDA Announces Label and Indication Changes for the Antibiotic Ketek
FDA today announced revisions to the labeling for the antibiotic Ketek (telithromycin) designed to improve the safe use of Ketek by patients. The changes include the removal of two of the three previously approved indications -- acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis -- from the drug's label.

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FDA Warns Consumers Not to Use Wild Kitty Cat Food Due to Salmonella Contamination
The specific products covered by this warning are Wild Kitty Raw All Natural, Frozen Cat Food -- Chicken with Clam Recipe, Net Wt. 3.5 oz (100g) and 1 lb in plastic containers. Some of these containers may be uncoded.

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New Clinical Data for PROSTASCINT(R) and QUADRAMET(R) in Prostate Cancer Presented at the 2007 Prostate Cancer Symposium (RedNova)
Cytogen Corporation (NASDAQ: CYTO) today report

St. Jude Medical Receives FDA Clearance for Venture Catheter With New Delivery Platform (RedNova)
St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) clearance for the VentureTM Wire Control Catheter on a rapid exchange delivery platform, a delivery design that accommodates shorter guidewires and may result in quicker, easier coronary procedures.

Merck is on the mend (CNN Money)
In the dark autumn of 2004, when Merck withdrew its blockbuster heart drug Vioxx over concerns it caused cardiac arrest, the company lost roughly a third of its market value within days. But in 2006, Merck's shares quietly surged 40%. What's more, there may be enough upside left to this recovery to make the company a solid long-term investment again.

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Pro-Pharmaceuticals Meeting Scheduled with the FDA (Business Wire via Yahoo! Finance)
NEWTON, Mass.----Pro-Pharmaceuticals, Inc. , a developer of novel carbohydrate compounds, today announced that a meeting with the U.S. Food & Drug Administration is scheduled for April 11th to discuss data and plans for submitting a New Drug Application , under Section 505 for DAVANAT to be co-administered with 5-Fluorouracil to treat cancer patients. 5-FU is one of the most widely used ...

Caremark Mails Supplemental Disclosures; Shareholder Vote to Be Held on March 16 (Business Wire via Yahoo! Finance)
NASHVILLE, Tenn.----Caremark Rx, Inc. today mailed supplemental disclosures regarding shareholder appraisal rights and the structure of fees to its financial advisors in connection with Caremark's planned merger with CVS .

Sparta Systems Announces Software For Electronic Submission Of Medical Device Reports To Food And Drug Administration ... (PharmaceuticalOnline)
Sparta Systems, Inc. (Sparta), the maker of TrackWise, and the market leader in enterprise quality and compliance process management software, today announced that it has released the Beta version of the TrackWise eMDR Submission Manager software.

Read more about Pro-Pharmaceuticals Meeting Scheduled with the FDA (Business Wire via Yahoo!

Merck is on the mend (CNN Money)
In the dark autumn of 2004, when Merck withdrew its blockbuster heart drug Vioxx over concerns it caused cardiac arrest, the company lost roughly a third of its market value within days. But in 2006, Merck's shares quietly surged 40%. What's more, there may be enough upside left to this recovery to make the company a solid long-term investment again.

Edwards gets warning letter from FDA (Orange County Register)
The agency won't approve new products until the heart valve company upgrades certain quality systems.

Read more about FDA Approvals - Merck is on the mend (CNN Money) In the dark

FDA Proposes to Strengthen Label Warning for Xolair
The boxed warning emphasizes that Xolair, used to treat patients with asthma related to allergies, may cause anaphylaxis.

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Cardinal Health 303, Inc. Signs Consent Decree with FDA, Agrees to Correct Manufacturing Deficiencies
The U.S. Food and Drug Administration (FDA) today announced that Cardinal Health 303 Inc. (Cardinal 303), formerly known as Alaris Medical Systems, Inc., and three of its top executives, have signed a consent decree for condemnation and permanent injunction related to their Signature Edition (SE) infusion pumps.

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INTROL? CF Panel I Control
INTROL? CF Panel I Control is DNA quality control material that is used to monitor the performance of genetic tests used in the detection of variations in the gene called cystic fibrosis transmembrane conductance regulator (CFTR) in human blood specimens. (Approved: 9/18/2006)

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Ho's Trading Inc. Issues Alert on Undeclared Sulfites in Fortune Star Brand Dried Lily Bulb
The recalled Fortune Star Brand Dried Lily Bulb is packed in 10 oz., uncoded plastic bags. The products were sold nationwide.

Counterfeit Liviro3 Discovered After Voluntary Recall Announcement
Consumers who have either the genuine or counterfeit Liviro3 product in their possession should stop using it immediately and contact their physician if they have experienced any problem that may be related to taking either of these products.

Vitalabs, Inc. Issues Nationwide Allergy Alert on Undeclared Dairy Content in Egg Protein Powder
The recalled Egg Protein Powder were distributed nationwide in retail stores and through internet sales.

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