March 2006 - FDA News

Implications of Sarbanes-Oxley Section 404 with Scott Taub, Acting Chief

Implications of Sarbanes-Oxley Section 404 with Scott Taub, Acting Chief Accountant, SEC (PR Web)
Scott Taub, Acting Chief Accountant, SEC discusses Compliance Strategies to Evaluate Internal Control Effectiveness and the Implications of Sarbanes-Oxley Section 404. [PRWEB Mar 31, 2006] Trackback URI: http://www.prweb.com/zingpr.php/Q3Jhcy1QaWdnLVNxdWEtTG92ZS1IYWxmLVplcm8=

FDA Approvals - ArthroCare Receives FDA Clearance for Latest Vertebroplasty Innovation to Help

ArthroCare Receives FDA Clearance for Latest Vertebroplasty Innovation to Help Treat Vertebral Compression Fractures (Business Wire via Yahoo! Finance)
AUSTIN, Texas----March 30, 2006--ArthroCare Corp. , a multi-business medical device company that develops minimally invasive surgical products, announced today it received clearance from the U.S.

Today's Health Winners and Losers (TheStreet.com)
Nanogen surges after its first product is approved by the FDA.

FDA Approvals - Today's Health Winners and Losers (TheStreet.com) Nanogen surges after its

Today's Health Winners and Losers (TheStreet.com)
Nanogen surges after its first product is approved by the FDA.

FDA Approvals - Tm Bioscience reports 2005 year end results (PR Newswire via

Tm Bioscience reports 2005 year end results (PR Newswire via Yahoo! Finance)
Tm Bioscience Corporation , a leader in the commercial genetic testing market, today announced its financial and operational results for the year and fourth quarter ended December 31, 2005.

FDA Actions Weigh On Biotech Stocks (Forbes)
A look at the performance of sector newsmakers for the week of March 20.

Clinical Trials Packaging: A Few Issues Companies Can t Afford to

Clinical Trials Packaging: A Few Issues Companies Can t Afford to Miss (Medical Device Link)
While the focus of a clinical trial would seem to be the supplies the drug under study this isn t always the case. Industry experts say that clinical trial supplies are often almost an afterthought.

FDA Approvals - Consumer, Health and Family Law (Mondaq) The growing trend toward

Consumer, Health and Family Law (Mondaq)
The growing trend toward factoring ethical issues (also known as "other legitimate factors" in the framework of the Codex Alimentarius Commission) into food manufacturing, marketing and purchasing decisions is likely to continue, and perhaps even increase, over the course of the coming year.

Coming Soon: Faster, Yet Still Safe, Clinical Trials (HealthDay via Yahoo! News)
WEDNESDAY, March 29 (HealthDay News) -- In an ideal world, new, effective and safe medications would sail through clinical trials in just a couple of years.

Axcan submits FDA amendment to its new drug application for HELIZIDE (CNW Group via Yahoo! Finance)
Axcan Pharma Inc. announced today that it has submitted an amendment to its New Drug Application for HELIZIDE, its patented capsule therapy for the eradication of Helicobacter pylori.

Speeding Vaccine Production Techniques (PharmaceuticalOnline) The new FDA initiative aimed

Speeding Vaccine Production Techniques (PharmaceuticalOnline)
The new FDA initiative aimed at expediting the development of seasonal and pandemic flu vaccines underscores the universal drive to improve the quality and timeliness of vaccine availability

Microsoft Releases Microsoft Dynamics GP Extensions (SYS-CON Media)
Today at Convergence 2006, the Microsoft Business Solutions Group's customer conference, Microsoft Corp. announced the availability of Microsoft Dynamics(TM) GP 9.0 Extensions, a wide range of enhancements to the Microsoft Dynamics GP enterprise resource planning (ERP) solution that empower a user's mobility, strengthen compliance tracking and reporting capabilities, increase business process

Consumer, Health and Family Law (Mondaq) The growing trend toward

Consumer, Health and Family Law (Mondaq)
The growing trend toward factoring ethical issues (also known as "other legitimate factors" in the framework of the Codex Alimentarius Commission) into food manufacturing, marketing and purchasing decisions is likely to continue, and perhaps even increase, over the course of the coming year.

Microsoft Releases Microsoft Dynamics GP Extensions (SYS-CON Media) Today at

Microsoft Releases Microsoft Dynamics GP Extensions (SYS-CON Media)
Today at Convergence 2006, the Microsoft Business Solutions Group's customer conference, Microsoft Corp. announced the availability of Microsoft Dynamics(TM) GP 9.0 Extensions, a wide range of enhancements to the Microsoft Dynamics GP enterprise resource planning (ERP) solution that empower a user's mobility, strengthen compliance tracking and reporting capabilities, increase business process

HCL signs agreement with Glenmark (Hindustan Times)
Leading IT solution provider HCL Technologies has signed an agreement with Glenmark Pharmaceuticals for implementing its comprehensive drug labelling framework, Easy Labeling Solution, developed specifically for pharmaceutical companies.

Pharmaceutical Marketing Compliance: A Path to Operational Excellence? (PR Web)
BusinessEdge Solutions Inc. experts to speak on operational excellence at the Strategic Pharmaceutical Marketing Seminar. [PRWEB Mar 29, 2006]

Spectrum Pharmaceuticals Announces Filing of Thirteenth ANDA, for an Injectable

Spectrum Pharmaceuticals Announces Filing of Thirteenth ANDA, for an Injectable Drug, With the FDA (PR Newswire via Yahoo! Finance)
Spectrum Pharmaceuticals, Inc. announced that it has filed its thirteenth Abbreviated New Drug Application , which is for an injectable drug, with the U.S. Food and Drug Administration .

Stan Hochman | Schmidt strikes out as author (Philly.com) MIKE

Stan Hochman | Schmidt strikes out as author (Philly.com)
MIKE SCHMIDT'S new book, "Clearing the Bases," is about as thin as Kate Moss and almost as sad. He tiptoes around the amphetamine issue in one chapter, admitting "greenies" were readily available in the Phillies clubhouse when he played.

Bristol-Myers Squibb Plans To Build Biologics Facility In The U.S.

Bristol-Myers Squibb Plans To Build Biologics Facility In The U.S. (PharmaceuticalOnline)
Bristol-Myers Squibb Company said recently that it will build its new biologics facility in the United States

Bausch & Lomb Offers Lens Solution Pdt Exch In Singapore

Bausch & Lomb Offers Lens Solution Pdt Exch In Singapore (Dow Jones via Yahoo! Asia News)
SINGAPORE (Dow Jones)--U.S. eyecare-product maker Bausch & Lomb Inc. (BOL) Friday said it will offer a two-week voluntary product exchange program for ReNu contact lens solution users in Singapore.

FDA Launches Medical Device Postmarket Safety Initiative (Medical Device Link)

FDA Launches Medical Device Postmarket Safety Initiative (Medical Device Link)
Gottlieb: FDA to get postmarket makeover. Following what FDA describes as a comprehensive, year-long internal inventory of the tools used to monitor the postmarket safety of medical devices, the agency has announced that it is launching a new "postmarket transformation initiative."

Prescriptions - Kamada Receives Final FDA Approval to Commence Phase III Clinical

Kamada Receives Final FDA Approval to Commence Phase III Clinical Trials of API with Congenital Emphysema Patients (Business Wire via Yahoo! Finance)
REHOVOT, Israel----March 9, 2006--Kamada , a bio-pharmaceutical company which develops, manufactures and markets prescription drugs, today announced the crossing of a major milestone on its API roadmap with the FDA announcing the removal of the "Clinical Hold" status.

NNFA urges FDA to target 'unscrupulous' companies (Nutraingredients.com) 3/9/2006 -

NNFA urges FDA to target 'unscrupulous' companies (Nutraingredients.com)
3/9/2006 - In the aim of generating awareness of the difference between dietary supplements and illegal drugs, the National Nutritional Foods Association (NNFA) has today reinforced its stance against amending the present legal framework that defines FDA s relationship with the dietary supplement industry.

Abbott gets regulators' OK for blood glucose system (San Francisco

Abbott gets regulators' OK for blood glucose system (San Francisco Chronicle)
Abbott Laboratories Inc. said Monday it has received approval from the U.S. Food and Drug Administration for a new blood glucose monitoring system, an announcement that propelled its stock to a six-month high. Abbott's diabetes care unit in Alameda,...

US FDA issues guidance on hospital bed design to reduce

US FDA issues guidance on hospital bed design to reduce patient entrapment (PharmaBiz)
The US Food and Drug Administration published final guidance designed to reduce the occurrence of hospital bed entrapments. Entrapment can occur when part of a patient's body becomes caught between parts of the bed, such as in the space between the mattress and the side rail.

Sandwiches Recalled: "Egg Salad on Vienna Bread, Pilot Good to

Sandwiches Recalled: "Egg Salad on Vienna Bread, Pilot Good to Go" (WTOL News 11)
The product may be contaminated with Listeria monocytogenes -- an organism that can cause serious and sometimes fatal infections in children, frail or elderly people, and others with weakened immune systems.

Food & Drink Packaging & Machinery: FDA OK (RedNova) STANELCO

Food & Drink Packaging & Machinery: FDA OK (RedNova)
STANELCO has announced that the USA's Food and Drug Administration has granted full food contact approval for all food categories for its Starpol 2000 biodegradable packaging material.