FDA Warns Obesity Doctor Over Implants (RedNova)
WASHINGTON - A Los Angeles-area doctor who lent his name to a type of stomach-shrinking surgery failed to obtain the full informed consent of 175 patients implanted with an experimental medical device, according to a federal warning letter released Tuesday. Dr. Mathias A.L.

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FDA Revamps Process for Safety of Drugs After Approval (Washington Post)
The Food and Drug Administration said yesterday that it is making changes in the way it operates to prevent the kind of drug safety controversies that have dogged the agency in recent years.

Ranbaxy Gains FDA Approval to Market Amoxicillin and Clavulanate Potassium for Oral Suspension USP (PR Newswire via Yahoo! Finance)
Ranbaxy Pharmaceuticals Inc. , a wholly owned subsidiary of Ranbaxy Laboratories Limited , announced today that RLL has received approval from the U.S. Food and Drug Administration to market Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg / 5 mL.

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FDA Grants Boston Scientific Clearance To Expand PolarCath(TM) Peripheral Dilatation System Offering With New Balloon ... (Medical News Today)
Boston Scientific Corporation (NYSE: BSX) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration to expand its PolarCath(TM) Peripheral Dilatation System offering to include a 100-millimeter (mm) balloon. [click link for full article]

Nephros Receives Conditional Approval from the FDA of Investigational Device Exemption Application (Business Wire via Yahoo! Finance)
NEW YORK----Nephros, Inc. today reported that the Company received conditional approval for its Investigational Device Exemption application from the Food and Drug Administration to begin a human clinical trial of the Company's OLpur H2H Hemodiafiltration Module and OLpur MD 220 Hemodiafilter.

Critical Therapeutics Licenses Rights for Vagus Nerve Stimulation Device to Innovative Metabolics (RedNova)
Critical Therapeutics, Inc. (Nasdaq: CRTX) has granted an exclusive worldwide license to Innovative Metabolics, Inc.

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FDA Issues Draft Documents on the Safety of Animal Clones
FDA today issued three documents on the safety of animal cloning -- a draft risk assessment; a proposed risk management plan; and a draft guidance for industry.

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Akzo Nobel May Get Three Buyout Offers for Organon (Update3) (Bloomberg.com)
Jan. 12 (Bloomberg) -- Akzo Nobel NV, the Dutch chemicals maker, may next week receive offers from at least three groups of buyout firms for its pharmaceutical division, which may be worth more than 8 billion euros ($10.3 billion).

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FDA Proposes New Measures to Strengthen Drug Safety Under PDUFA Reauthorized User Fee Program
The Food and Drug Administration (FDA) today proposed recommendations to Congress for the next reauthorization of the Prescription Drug User Fee program which, if adopted, would significantly broaden and upgrade the agency's drug safety program, increase resources for review of television drug advertising, and facilitate more efficient development of safe and effective new medications for the American public.

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ARCHITECT HBsAg Assay
These reagents are used with the Abbott ARCHITECT Instrument System to identify certain virus proteins associated with hepatitis B virus (HBV). If these virus proteins are present, then the patient is likely to be infected with HBV. (Approved: 9/7/2006)

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Kellogg Company Issues Allergy Alert on Undeclared Milk in Kellogg's Pop-Tarts Frosted Blueberry Toaster Pastries
Kellogg Company of Battle Creek, MI is recalling a limited number of cartons of Kellogg's Pop-Tarts Frosted Blueberry toaster pastries because they may contain undeclared milk.

Lesley Elizabeth Inc. Issues Nationwide Allergy Alert on Undeclared Sulfites in products containing Sun dried Tomatoes
Anyone who is allergic to sulfites should not consume these products. People who are allergic to sulfites and eat these products run the risk of an allergic reaction that may vary from mild to life threatening.

East Coast Foods Inc. Issues an Alert on Uneviscerated Fish
East Coast Foods Inc., 2723 W. 15th St. Brooklyn, N.Y., 11224, is recalling 48 cans of Kaija brand uneviscerated Herring in Special Brine. This product may be contaminated with Clostridium botulinum spores, which can cause botulism.

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FDA Approves Novel Device That Prevents or Reduces Brain Damage in Infants
The Olympic Cool-Cap system is designed to prevent or reduce damage to the brains of these patients by keeping the head cool while the body is maintained at a slightly below-normal temperature.

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MDS buys U.S.-based Molecular Devices in bid for more customers, products (CP via Yahoo! Canada News)
TORONTO (CP) - MDS Inc. (TSX:MDS) is acquiring Molecular Devices Corp., a California-based bio-analytical measurement systems maker, in a US$615-million cash deal that will enable the Canadian life sciences company to reach more customers and offer a wider array of products.

Schering-Plough hits earnings goal (CNN Money)
Cholesterol drugs Vytorin and Zetia and arthritis remedy Remicade push profits up sharply, meeting expectations.

Panel Recommends That FDA Not Create Specific Effectiveness Standard For Oral Contraceptive Approvals (Medical News Today)
A panel of gynecologists, researchers and other medical experts on Wednesday at the end of a two-day meeting convened by FDA recommended the agency not set a specific standard of effectiveness for approval of oral contraceptives, the AP/Minneapolis Star Tribune reports (Bridges, AP/Minneapolis Star Tribune, 1/25). [click link for full article]

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Software Solutions: Building Blocks For FDA Compliance (Logistics Management)
Medical device manufacturers have long embraced enterprise resource planning and customer relationship management software systems; however, they have primarily employed them to achieve operational efficiencies as well as further sales and marketing objectives.

Schering pays $435m to settle probe (Financial Times)
Schering-Plough , the US drugmaker, on Tuesday pleaded guilty to conspiracy to mislead the government and agreed to pay $435m, resolving a six-year Department of Justice investigation into alleged illegal sales and marketing practices.

Feb. 2 deadline set for Girl Scout cookie orders (DeWitt-Bath Review)
BATH Every year, thousands of girls across the area gain valuable knowledge while providing the community with a special treat - Girl Scout cookies. This year will be no exception.

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Congress Likely To Debate Moratoriums On Direct-to-Consumer Prescription Drug Advertisements (Medical News Today)
Congress this session likely will debate the FDA review system for prescription drug direct-to-consumer advertisements during hearings on renewing user fees that manufactures pay the agency for quicker drug approvals, according to industry critics, the New York Times reports. [click link for full article]

BioSphere Medical Announces That a Live-Case and Scientific Presentation Featuring BioSphere's QuadraSphere ... (RedNova)
BioSphere Medical (NASDAQ: BSMD) announced toda

FDA reforms seek right dose (Winston-Salem Journal)
Revlimid can't cure Alice Duggins, but it can buy her time. Duggins has a blood disorder that can lead to leukemia, and while she waits for a bone-marrow transplant, Revlimid boosts her red-blood-cell count.

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Randall Lutter Appointed Acting Deputy Commissioner for Policy
Dr. Andrew von Eschenbach, Commissioner of Food and Drugs (FDA), today announced that Randall Lutter, Ph.D., will serve as Acting Deputy Commissioner for Policy.

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BioSphere Medical Announces That a Live-Case and Scientific Presentation Featuring BioSphere's QuadraSphere ... (RedNova)
BioSphere Medical (NASDAQ: BSMD) announced toda

Oscient Pharmaceuticals Completes Enrollment in Phase IV Trial of FACTIVE Tablets (Business Wire via Yahoo! Finance)
WALTHAM, Mass.----Oscient Pharmaceuticals Corporation has completed enrollment in its Phase IV post-marketing trial for its fluoroquinolone antibiotic, FACTIVE tablets. Known as the FORCE trial , Oscient began enrollment coincident with the launch of FACTIVE in the fall of 2004.

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FDA Updates Health Claim for Calcium and Osteoporosis
The Food and Drug Administration (FDA) is proposing to allow new claims on foods and dietary supplements containing calcium and Vitamin D to show their potential to reduce the risk of osteoporosis.

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FDA Approves LIALDA (mesalamine), The First Oral Once-Daily Mesalamine For Patients With Active, Mild To Moderate ... (Medical News Today)
Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that the U.S. Food and Drug Administration (FDA) has approved LIALDATM (mesalamine) with MMX(R) technology, indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. LIALDA is the first and only FDA-approved once-daily oral formulation of mesalamine. [click link for full article]

Averion Signs Agreement with India CRO Apothecaries to Expand Core Oncology Competencies and Global Presence (Business Wire via Yahoo! Finance)
BOSTON----Averion International Corp. , a clinical research organization specializing in oncology, medical devices, dermatology and nephrology, today announced that is has signed a non-exclusive agreement with Apothecaries Ltd. of New Delhi, India, a full-service CRO with a focus on oncology.

ThinSpring Announces Appointment of John G. McGraw as Senior Account Executive for Retail Software Business Unit (PR Web via Yahoo! News)
Bridgewater, NJ (PRWeb) January 26, 2007 -- ThinSpring, a leading provider of XML-based solutions such as SPL Server and the United States Food and Drug Administration's (FDA) Electronic Labeling Information Processing System (ELIPS), is announcing that John G.

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FDA Proposes New Measures to Strengthen Drug Safety Under PDUFA Reauthorized User Fee Program
The Food and Drug Administration (FDA) today proposed recommendations to Congress for the next reauthorization of the Prescription Drug User Fee program which, if adopted, would significantly broaden and upgrade the agency's drug safety program, increase resources for review of television drug advertising, and facilitate more efficient development of safe and effective new medications for the American public.

Read more about FDA Proposes New Measures to Strengthen Drug Safety Under PDUFA

Akzo Nobel May Get Three Buyout Offers for Organon (Update3) (Bloomberg.com)
Jan. 12 (Bloomberg) -- Akzo Nobel NV, the Dutch chemicals maker, may next week receive offers from at least three groups of buyout firms for its pharmaceutical division, which may be worth more than 8 billion euros ($10.3 billion).

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AxSYM AUSAB Reagent Kit, Calibrator and Controls
The device is a lab test used to determine whether a person is, or has been, infected with the hepatitis B virus (HBV), or to determine whether a patient needs to be vaccinated with HBV vaccine. (Approved: 8/7/2006)

Read more about AxSYM AUSAB Reagent Kit, Calibrator and Controls The device is

Lesley Elizabeth Inc. Issues Nationwide Allergy Alert on Undeclared Sulfites in products containing Sun dried Tomatoes
Anyone who is allergic to sulfites should not consume these products. People who are allergic to sulfites and eat these products run the risk of an allergic reaction that may vary from mild to life threatening.

El Norteno Distributors, Corp. Issues Nationwide Allergy Alert on Undeclared Eggs in Brown Corn Cookies (Rosquete De Maiz)
The recalled products were distributed nationwide in retail stores and through mail orders.

Kellogg Company Issues Allergy Alert on Undeclared Milk in Kellogg's Pop-Tarts Frosted Blueberry Toaster Pastries
Kellogg Company of Battle Creek, MI is recalling a limited number of cartons of Kellogg's Pop-Tarts Frosted Blueberry toaster pastries because they may contain undeclared milk.

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