FDA Selects Members for Risk Communication Advisory Committee
The U.S. Food and Drug Administration has selected 15 voting members to serve on its Risk Communication Advisory Committee.

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Welcome to the New Era of FDA Regulation (The Motley Fool)
FDA approvals are not keeping pace with drugmakers' push to get new compounds on the market.

Signalife Receives FDA Clearance For OTC Non-Prescription Event Recorder Device (Medical News Today)
Signalife, Inc. (Amex: SGN - News) has received FDA 510(k) clearance to market and sell - without prescription - its ambulatory event recorder throughout the United States. [click link for full article]

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FDA Clears Silver-Coated Breathing Tube for Marketing
The U.S. Food and Drug Administration today announced that it has cleared for marketing a breathing tube coated with a thin layer of silver. The coating, a material known to have antimicrobial properties, reduces the risk that patients on ventilators will acquire pneumonia while in the hospital.

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Approximately $2 Million of Potentially Harmful "Cosmetic" Eye Product Seized
At the request of the U.S. Food and Drug Administration, U.S. Marshals seized today 12,682 applicator tubes of Age Intervention Eyelash, a product that may, in some users, lead to decreased vision.

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N.Y. budget deficit tied to declining tax revenues (Press & Sun-Bulletin)
ALBANY -- A decline in tax revenues in a slowing economy will result in a $4.3 billion budget deficit, $651 million worse than projected in July, according to a budget report issued Tuesday.

Schering-Plough Completes Acquisition of Organon BioSciences (The San Francisco Examiner)
KENILWORTH, N.J. ( Map ) - KENILWORTH, N.J., Nov. 19 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP ) today announced that it has completed the acquisition of Organon BioSciences N.V., creating a stronger combined company with broader human and animal health portfolios, an enhanced pipeline and increased R&D capabilities.

Schering-Plough acquires Organon BioSciences (News-Medical-Net)
Schering-Plough Corporation has announced that it has completed the acquisition of Organon BioSciences N.V., creating a stronger combined company with broader human and animal health portfolios, an enhanced pipeline and increased R&D capabilities. Schering-Plough's agreement to acquire Organon BioSciences was announced on March 12, 2007.

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FDA SITES (Pharmaceutical Executive)
The FDA home page is a deceptively simple door to a lot of information. Unless otherwise noted, nothing on the site is copyrighted -- neither text nor graphics. The public-domain material may be republished, reprinted, and used freely by anyone without obtaining permission from FDA.

Akorn, Inc. Announces FDA Approval For Unit Dose Preservative Free Tetanus Diphtheria Vaccine (Medical News Today)
Akorn, Inc. (NASDAQ:AKRX) announced FDA approval of a supplemental Biologics License Application (BLA) for a unit dose preservative free Tetanus Diphtheria vaccine. Akorn expects to launch this new vaccine in the first quarter of 2008. [click link for full article]

Natus reopens Seattle facility (bizjournals.com via Yahoo! Finance)
Natus Medical Inc. has resumed production and shipping operations at its Seattle facility, which was closed after an FDA inspection.

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FLAIR Endovascular Stent Graft
The FLAIR Endovascular Stent Graft is used to treat a stenosis, a narrowing or blockage, which has developed at the connection of a vein and an arteriovenous (A-V) access graft, known as the venous anastomosis. An A-V access graft acts as an artificial... (Approved: 7/23/2007)

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Sweetwater Valley Farms, Inc. Recalls Southern Cheddar Jack Volunteer Special Cheese (Nov. 21)
Sweetwater Valley Farms, Inc. of Philadelphia, TN is recalling Southern Cheddar Jack Volunteer Special Cheese because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

Del Rey Tortilleria, Inc. Issues Recall of Flour Tortillas Due to Possible Health Risk (Nov. 12)
Included in the recall are flour tortillas of all sizes [White Flour Tortillas; Tortillas de Harina(6 inch); Burritos 2, 3, and 4; and Fajita 8" size] with the name "Del Rey" on the label, and with one of these Date Codes: OCT/17/07; OCT/20/07; OCT/24/07; NOV/04/07; NOV/10/07; or NOV/11/07.

President Global Corp. Issues Allergy Alert on Undeclared Skim Milk in Uni-President Red Bean Flavor Ice Bars and Red Bean Tapioca Flavor Ice Bars (Nov. 28)
President Global Corporation of Buena Park, CA 90620 is recalling Uni-President Red Bean Flavored Ice Bars (Tung-I Red Bean Flavor Ice Bars) 6/3 fl oz and Red Bean Tapioca Ice Bars (Tung-I Red Bean Tapioca Ice Bars) 6/2.83 fl oz because they may contain undeclared skim milk.

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FDA SITES (Pharmaceutical Executive)
The FDA home page is a deceptively simple door to a lot of information. Unless otherwise noted, nothing on the site is copyrighted -- neither text nor graphics. The public-domain material may be republished, reprinted, and used freely by anyone without obtaining permission from FDA.

Welcome to the New Era of FDA Regulation (The Motley Fool)
FDA approvals are not keeping pace with drugmakers' push to get new compounds on the market.

Read more about FDA Approvals - FDA SITES (Pharmaceutical Executive) The FDA home page is a

FDA Says Consumers Continue to Buy Risky Drugs Online
A yearlong U.S. Food and Drug Administration (FDA) investigation into drugs mailed to the United States from foreign countries suggests that consumers may be buying drugs online to avoid the need for a prescription from their physician. The FDA sampling of imported drugs also indicates that consumers continue to spend money unnecessarily on potentially risky drug products bought over the Internet.

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St. Jude Medical Announces FDA Approval Of Epic Stented Tissue Valve With Anti-Calcification Technology (Medical News Today)
St. Jude Medical, Inc. (NYSE:STJ) announced U.S. Food and Drug Administration (FDA) approval of its Epic(TM) Stented Tissue Valve with Linx(TM) AC Technology. Identical in design to the company's Biocor(TM) Valve, which currently leads the tissue valve industry in U.S. [click link for full article]

Merit Medical Announces 510(k) Notification for Two Additional Products (PrimeNewswire via Yahoo! Finance)
SOUTH JORDAN, Utah, Nov. 28, 2007 -- Merit Medical Systems Inc. , a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology and radiology procedures, announced today that it has received notification from the FDA of 510 clearance for the All Star hemostasis valve and the Prelude marker tip introducer sheath.

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FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug Avandia
The U.S. Food and Drug Administration announced today that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug's labeling about potential increased risk for heart attacks.

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Life Sciences Industry Facing New Challenges with the FDA's Latest Electronic Submissions Requirements (PRWeb via Yahoo! News)
Companies filing electronic submissions must use new Electronic Common Technical Document (eCTD) format by Jan. 1, 2008. An integrated process for regulated content will help companies create, review, maintain and archive electronic submissions. Are companies ready?

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St. Jude Medical Announces FDA Approval of Epic Stented Tissue Valve with Anti-Calcification Technology (Business Wire via Yahoo! Finance)
ST. PAUL, Minn.----St. Jude Medical, Inc. today announced U.S. Food and Drug Administration approval of its Epic Stented Tissue Valve with Linx AC Technology. Identical in design to the company's Biocor Valve, which currently leads the tissue valve industry in U.S. market share growth, the Epic Valve also incorporates patented anti-calcification technology designed to protect against tissue ...

St. Jude Medical Announces FDA Approval Of Epic Stented Tissue Valve With Anti-Calcification Technology (Medical News Today)
St. Jude Medical, Inc. (NYSE:STJ) announced U.S. Food and Drug Administration (FDA) approval of its Epic(TM) Stented Tissue Valve with Linx(TM) AC Technology. Identical in design to the company's Biocor(TM) Valve, which currently leads the tissue valve industry in U.S. [click link for full article]

Read more about FDA Approvals - St. Jude Medical Announces FDA Approval of Epic Stented Tissue

FDA Announces Board Members of Reagan-Udall Foundation
The U.S. Food and Drug Administration (FDA) has announced the board members and chair of the Reagan-Udall Foundation. The private and independent nonprofit organization will advance FDA's mission to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.

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Hopkins report: Next generation contraceptive implants are cheaper, highly effective, and available now (News-Medical-Net)
The next generation of contraceptive implants offer an extremely effective way to expand family planning choices for women and reduce the incidence of maternal mortality worldwide, according to the latest issue of Population Reports, from the Johns Hopkins Bloomberg School of Public Health.

Advertisement starts (Tiscali)
The move gets U.S.-based Schering-Plough a near $5 billion-a-year (2.5 billion pound) business in women s health, central nervous system drugs and animal medicine, and marks the breakup of one of Europe s last hybrid chemical-pharmaceutical companies.

N.Y. budget deficit tied to declining tax revenues (Press & Sun-Bulletin)
ALBANY -- A decline in tax revenues in a slowing economy will result in a $4.3 billion budget deficit, $651 million worse than projected in July, according to a budget report issued Tuesday.

Read more about Hopkins report: Next generation contraceptive implants are cheaper, highly effective,

Aurobindo receives US FDA approval for five products (PharmaBiz)
The Hyderabad based leading pharmaceutical company Aurobindo Pharma has received five product approvals from the US Food and Drug Administration since October 2007 for the US market.

(AFX UK Focus) 2007-11-23 15:37 GMT: Roche says on course to meeting product approvals target (Interactive Investor)
ZURICH (Thomson Financial) - Roche Holdings AG said it is well on course in meeting its targeted product approvals for this and next year, having already secured half of its target.

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FDA Strengthens Boxed Warnings, Approves Other Safety Labeling Changes for Erythropoiesis-Stimulating Agents (ESAs)
These new statements address the risks that the drugs Aranesp, Epogen and Procrit pose to patients with cancer and patients with chronic kidney failure.

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Epicel® cultured epidermal autograft (CEA)
Epicel cultured epidermal autografts (CEAs), or skin grafts, are sheets of autologous keratinocytes (skin cells) used to replace the epidermal, or top layer of skin on severely burned patients. The patient?s own skin cells are grown or cultured from a... (Approved: 10/25/2007)

Read more about Epicel® cultured epidermal autograft (CEA) Epicel cultured epidermal autografts (CEAs),

Le Gourmet Connection Recalls Jack Cheese (Nov. 21)
Le Gourmet Connection of Lebanon, TN is recalling Jack Cheese, lot number 539, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

Harry & David recalls Harry and David Moose Munch Confection tubs in two flavor combinations: Milk & Dark Chocolate, White Chocolate Macadamia and Peanut Butter, Milk Chocolate, Macadamia Nut for undeclared nut allergen (Nov. 21)
Harry & David Operations Corp., of Medford, Oregon, is voluntarily recalling approximately 5880 tubs of the Milk & Dark Chocolate, White Chocolate Macadamia because they may contain macadamia nuts not declared on the ingredient statement, and 4400 tubs of the Peanut Butter, Milk Chocolate, Macadamia Nut because they may contain macadamia nuts and peanuts not declared on the ingredient statement. People who have an allergy or severe sensitivity to these nuts (macadamia or peanut) run the risk of serious or life-threatening allergic reaction if they consume these products.

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