FDA Proposes Guidance for Dissemination of Information on Unapproved Uses of Medical Products
The U.S. Food and Drug Administration (FDA) today issued draft guidance on "Good Reprint Practices" for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.

Read more about FDA Proposes Guidance for Dissemination of Information on Unapproved Uses

Immunicon Corporation Announces FDA Clearance of the CellSearch(TM) Circulating Tumor Cell Kit for Monitoring Patients ... (Finanzen.net)
Immunicon Corporation (NASDAQ:IMMC) announced today that the FDA has cleared the CellSearch Circulating Tumor Cell (CTC) Kit as an aid in the monitoring of patients with metastatic prostate cancer. A sample of the patient s ...

Read more about Immunicon Corporation Announces FDA Clearance of the CellSearch(TM) Circulating Tumor

Sirion Therapeutics Receives NDA Acceptance And Priority Review From The FDA For Durezol(TM) In The Treatment Of ... (Medical News Today)
Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced that its New Drug Application (NDA) for Durezol(TM) has been accepted by the U.S. Food and Drug Administration (FDA) and granted priority review. Sirion Therapeutics is seeking approval from the FDA for its investigational compound Durezol(TM) (difluprednate ophthalmic emulsion) 0.

Center For Molecular Medicine Among First To Offer New FDA Approved Test To Aid In Treatment Of Prostate Cancer (Medical News Today)
The Center for Molecular Medicine (CMM) announced it is one of the first laboratories in the nation to offer a new, FDA-approved test that will aid in the treatment of metastatic prostate cancer. The CMM (http://www.cmmdx.org) is offering the CellSearch(TM) System from Veridex (http://www.veridex.

FDA Accepts For Review OVATION's Two NDA Submissions For Sabril(R) (Medical News Today)
OVATION Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company's new drug applications (NDA) for Sabril (vigabatrin) in two types of epilepsies. The FDA assigned a priority NDA review for Sabril for the treatment of Infantile Spasms (IS), and will review the submission for refractory complex partial seizures (CPS) in the same time frame.

Read more about FDA Approvals - Sirion Therapeutics Receives NDA Acceptance And Priority Review From The

Sirion Therapeutics Receives NDA Acceptance And Priority Review From The FDA For Durezol(TM) In The Treatment Of ... (Medical News Today)
Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced that its New Drug Application (NDA) for Durezol(TM) has been accepted by the U.S. Food and Drug Administration (FDA) and granted priority review. Sirion Therapeutics is seeking approval from the FDA for its investigational compound Durezol(TM) (difluprednate ophthalmic emulsion) 0.

Boston Scientific gets 3 new FDA approvals (BizJournals)
Boston Scientific Corp. has a shot of good news this week with three separate federal regulatory approvals of its products. (BSX)

Boston Scientific Announces Three FDA Product Approvals for Its Cardiac Rhythm Management Business (The San Francisco Examiner)
NATICK, Mass. ( Map ) - NATICK, Mass., Feb. 25 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX ) today announced U.S. Food and Drug Administration (FDA) approval for three products in its Cardiac Rhythm Management business.

Read more about FDA Approvals - Sirion Therapeutics Receives NDA Acceptance And Priority Review From The

FDA Approves New Orphan Drug for Treatment of Rare Inflammatory Syndromes
The U.S. Food and Drug Administration today approved a drug to help ease the suffering faced by those with certain chronic inflammatory diseases. Arcalyst (rilonacept, an Interleukin-1 blocker) is now approved for the long term treatment of two Cryopyrin-Associated Periodic Syndromes (CAPS) disorders: Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

Read more about FDA Approves New Orphan Drug for Treatment of Rare Inflammatory

FDA Approves New Orphan Drug for Treatment of Rare Inflammatory Syndromes
The U.S. Food and Drug Administration today approved a drug to help ease the suffering faced by those with certain chronic inflammatory diseases. Arcalyst (rilonacept, an Interleukin-1 blocker) is now approved for the long term treatment of two Cryopyrin-Associated Periodic Syndromes (CAPS) disorders: Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS).

Read more about FDA Approves New Orphan Drug for Treatment of Rare Inflammatory

Health worker jailed for abusing girls (Adelaide Now)
AN Aboriginal health worker has been sentenced to three years in prison for sexually abusing two teenage girls, one of whom he took to have a contraceptive device inserted in her arm.

Health worker sexually abused girls (Perth Now)
AN Aboriginal health worker has been jailed for three years after he sexually abused two teenage girls, taking one girl to have a contraceptive device inserted.

Health worker jailed for abusing girls (The West Australian)
An Aboriginal health worker has been sentenced to three years in prison for sexually abusing two teenage girls. The 52-year-old had faced up to 16 years prison on each of the four counts of unlawful sex with a child that he pleaded guilty to in October last year.

Read more about Health worker jailed for abusing girls (Adelaide Now) AN Aboriginal

FDA Advises Seafood Processors About Ciguatera Fish Poisoning in the Northern Gulf of Mexico Near the Flower Garden Banks National Marine Sanctuary
The U.S. Food and Drug Administration (FDA) today issued a letter to seafood processors, advising them of recent illnesses linked to consuming fish carrying the ciguatera toxin, which has led to cases of ciguatera fish poisoning (CFP) in consumers.

Read more about FDA Advises Seafood Processors About Ciguatera Fish Poisoning in the

SoftLight Development Introduces Telerad: Web-Based Teleradiology Service With FDA-Compliant Web Viewer (Medical News Today)
SoftLight Development unveiled its new Web-based teleradiology study management service, called Telerad, at the HIMSS exhibition in Orlando.

Read more about SoftLight Development Introduces Telerad: Web-Based Teleradiology Service With FDA-Compliant Web

AMPLATZER® Muscular VSD Occluder
The AMPLATZER Muscular VSD Occluder is a device placed via a catheter into the muscular ventricular septum, which separates the two ventricles of the heart, in order to close a hole, known as a ventricular septal defect (VSD). The device consists of... (Approved: 9/7/2007)

Read more about AMPLATZER® Muscular VSD Occluder The AMPLATZER Muscular VSD Occluder

Summit Import Corporation Issues Allergy Alert on Undeclared Sulfites in Oriental Mascot Brand Sweetened Sliced Coconut (Feb. 1)
Summit Import Corp. is recalling "Oriental Mascot Brand Sweetened Sliced Coconut" because it contains undeclared sulfites. Consumers who have severe sensitivity to sulfites may run the risk of serious or life-threatening allergic reactions if they consume this product. The product comes in an uncoded 4 oz plastic container. The recalled "Oriental Mascot Brand Sweetened Sliced Coconut" was distributed in New York State.

Rocky Mountain Popcorn Company Issues Recall of Low Fat Caramel Popcorn (in the green bag) 9 oz. (Feb. 11)
Rocky Mountain Popcorn Company, Centennial, CO is voluntarily initiating a nationwide recall of 1,603 bags of Low Fat Caramel 9 oz. Popcorn (in the green bag). This recall is on the Low Fat variety only. An ingredient in this product has been found to contain a trace amount of tree nuts, which potentially could cause an allergic reaction to any person with a tree nut allergy.

Read more about Summit Import Corporation Issues Allergy Alert on Undeclared Sulfites in

GAO To Investigate Whether FDA Has Adequate Resources (Medical News Today)
The Government Accountability Office will investigate whether FDA has the staff and resources it needs to function properly, CongressDaily reports. GAO is the second outside group lawmakers have asked to examine the agency's deficiencies. GAO Health Care Director Marcia Crosse on Monday announced the investigation.

Congress Likely To Debate Source Of Funds For FDA Oversight Of Direct-to-Consumer Prescription Drug Advertisements (Medical News Today)
The FDA budget for oversight of direct-to-consumer prescription drug advertisements in fiscal year 2008 is "larger than the past five years combined," but "whether that level of funding will be sustained and continue to come from taxpayers -- or will be raised from drug makers through new user fees -- is likely to be battled out in Congress," USA Today reports. In FY 2008, FDA received $6.

Read more about FDA Approvals - GAO To Investigate Whether FDA Has Adequate Resources (Medical News

Boston Scientific gets 3 FDA approvals (Boston Globe)
Medical device maker Boston Scientific Corp. said Monday the U.S. Food and Drug Administration granted approval for three of its heart-related products: Confient, Livian and upgraded Latitude.

Breast Cancer Action Disagrees With FDA's Avastin Ruling (Medical News Today)
Breast Cancer Action (BCA) strongly disagrees with the Food and Drug Administration's decision giving accelerated approval to biotech company Genentech's application to market its drug Avastin as a treatment for metastatic breast cancer at this time. "The FDA has lowered the bar on the approval of breast cancer therapies.

Read more about FDA Approvals - Boston Scientific gets 3 FDA approvals (Boston Globe) Medical device

FDA Investigation Leads to Several Indictments for Importing Contaminated Ingredients Used in Pet Food
The U.S. Food and Drug Administration's (FDA) Office of Criminal Investigations announced that two Chinese nationals and the businesses they operate, along with a U.S. company and its president and chief executive officer, were indicted by a federal grand jury today in separate but related cases. The indictments are for their roles in a scheme to import products purported to be wheat gluten into the United States that were contaminated with melamine. These products were used to make pet food.

Read more about FDA Investigation Leads to Several Indictments for Importing Contaminated Ingredients

Boston Scientific Gets 3 FDA Approvals (AP via Yahoo! Finance)
Medical device maker Boston Scientific Corp. said Monday the U.S. Food and Drug Administration granted approval for three of its heart-related products: Confient, Livian and upgraded Latitude.

Arbios Receives Conditional Approval From The FDA To Initiate Pivotal Clinical Trial For SEPET(TM) (Medical News Today)
Arbios Systems, Inc. (OTC Bulletin Board: ABOS) announced that the Company has received conditional approval from the U.S.

Read more about FDA Approvals - Boston Scientific Gets 3 FDA Approvals (AP via Yahoo! Finance)

FDA Announces Permanent Injunction against Food Companies, Executives
The U.S. Food and Drug Administration today announced that Brownwood Acres Foods Inc., Cherry Capital Services Inc. (doing business as Flavonoid Sciences) and two of their top executives have signed a consent decree that effectively prohibits the companies and their executives from manufacturing and distributing any products with claims in the label or labeling to cure, treat, mitigate or prevent diseases.

Read more about FDA Announces Permanent Injunction against Food Companies, Executives The U.S.

Bennett: Board more active at hospital (Today's News-Herald)
In January, Martha Bennett, co-chair of Connecting Havasu, became chairman of Havasu Regional Medical Center's Board of Trustees.

SoftLight Development Introduces Telerad: Web-Based Teleradiology . Service with FDA-Compliant Web Viewer (InfoBolsa)
Service with FDA-Compliant Web Viewer 24/02/2008 14:00:00 Business Wire US3696041033 SoftLight Development today unveiled its new Web-based teleradiology study management service, called Telerad, at the HIMSS exhibition in Orlando.

Read more about Bennett: Board more active at hospital (Today's News-Herald) In January,

FDA Warns Public of Contaminated Syringes
The U.S. Food and Drug Administration (FDA) today announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.

Read more about FDA Warns Public of Contaminated Syringes The U.S. Food and

Schering-Plough Reports Financial Results for 2007 Fourth Quarter, Full Year (The San Francisco Examiner)
KENILWORTH, N.J. ( Map ) - KENILWORTH, N.J., Feb. 12 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP ) today reported financial results for the 2007 fourth quarter and full year, and commented on its ongoing integration of Organon BioSciences N.V. (OBS), which was acquired in November 2007 and includes the Organon human health business and Intervet animal health business.

Read more about Schering-Plough Reports Financial Results for 2007 Fourth Quarter, Full Year

FDA Licenses New Hemophilia Treatment (Medical News Today)
The U.S. Food and Drug Administration licensed a treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects approximately 15,000 individuals, almost exclusively males, in the United States.

FDA approves Avastin to treat breast cancer (San Francisco Chronicle)
The federal government gave the go-ahead Friday for biotech giant Genentech Inc. to market its blockbuster drug Avastin as a treatment for late-stage breast cancer, a move lauded by some but criticized by others concerned about the drug's efficacy and cost....

Avastin decision could set precedent / OK by FDA would not be based on patient survival rates (San Francisco Chronicle)
A decision expected today on federal approval for Genentech's Avastin cancer drug could have ramifications for all companies developing cancer medicines. Genentech made its case for Food and Drug Administration approval of Avastin using a widely debated...

Read more about FDA Approvals - FDA Licenses New Hemophilia Treatment (Medical News Today) The U.S.