Oxygen Biotherapeutics, Inc. Submits Request For Designation To FDA For Oxycyte(R)-based Wound Care Product (Medical News Today)
Oxygen Biotherapeutics, Inc. (OTCBB:OXBO) announced that the company has submitted a preliminary Request For Designation (RFD) to the FDA for its first wound care product. The RFD submission is part of a process with the FDA for determining which agency component will have primary jurisdiction for a drug, device or biological product.

Mylan receives final FDA approvals for generic Lamictal tablets (News-Medical-Net)
Mylan Inc has announced that its subsidiaries Mylan Pharmaceuticals Inc. and Genpharm ULC received final approvals from the U.S. Food and Drug Administration (FDA) for their Abbreviated New Drug Applications (ANDAs) for Lamotrigine Tablets.

U.S. FDA Approves Oraquick Advance(R) 12-Month Shelf Life Dating (Medical News Today)
OraSure Technologies, Inc. (NASDAQ: OSUR) announced today that the United States Food and Drug Administration (FDA) has approved its request for 12-month shelf life from the date of manufacture for its OraQuick ADVANCE Rapid HIV-1/2 Antibody Test.

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FDA Detects Melamine Contamination in Flavored Drink
The U.S. Food and Drug Administration (FDA) has increased inspections and product testing efforts in response to the melamine contamination problem which originated in Chinese dairy products. As a result of the FDA's on-going testing program, the agency has detected melamine contamination in Blue Cat Flavor Drinks. The distributor of the product, Tristar Food Wholesale Co. Inc., initiated a recall of several flavors of Blue Cat Flavor Drink, based on the FDA s findings. The FDA advises the public not to consume this product and recommends that retailers and food service operators remove the product from sale or service.

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FDA Detects Melamine Contamination in Flavored Drink
The U.S. Food and Drug Administration (FDA) has increased inspections and product testing efforts in response to the melamine contamination problem which originated in Chinese dairy products. As a result of the FDA's on-going testing program, the agency has detected melamine contamination in Blue Cat Flavor Drinks. The distributor of the product, Tristar Food Wholesale Co. Inc., initiated a recall of several flavors of Blue Cat Flavor Drink, based on the FDA s findings. The FDA advises the public not to consume this product and recommends that retailers and food service operators remove the product from sale or service.

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Veristat, ISI Choose Phase Forward WebSDM to Help Ensure Compliance with FDA Data Standards (Centre Daily Times)
Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced contract research organization (CRO) Veristat and submissions leader ISI have selected its Web Submission Data Manager (WebSDM ) application to help their clients submit CDISC SDTM-compliant data to the U.S. Food and Drug Administration (FDA). Phase Forward developed ...

FDA report finds multiple problems at peanut plant (KFDA-TV Amarillo)
Roaches, mold, and signs of a leaking roof were among numerous problems federal inspectors uncovered at a Georgia peanut butter plant.

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Mylan receives final FDA approvals for generic Lamictal tablets (News-Medical-Net)
Mylan Inc has announced that its subsidiaries Mylan Pharmaceuticals Inc. and Genpharm ULC received final approvals from the U.S. Food and Drug Administration (FDA) for their Abbreviated New Drug Applications (ANDAs) for Lamotrigine Tablets.

FDA Grants IND Status To Clinuvel's Photoprotective Afamelanotide (Medical News Today)
Melbourne-based Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it has obtained Investigational New Drug (IND) status for its photoprotective drug afamelanotide from the US Food and Drug Administration (FDA). Clinuvel can now commence clinical trials in the US, the world's largest pharmaceutical market.

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Savient Announces FDA's Advisory Panel To Review Pegloticase For Treatment Failure Gout Patients (Medical News Today)
Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) announced that its biologics license application (BLA) for pegloticase for treatment-failure gout will be reviewed by the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) on March 5, 2009 as required for a drug of a new therapeutic class.

FDA Grants IND Status To Clinuvel's Photoprotective Afamelanotide (Medical News Today)
Melbourne-based Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it has obtained Investigational New Drug (IND) status for its photoprotective drug afamelanotide from the US Food and Drug Administration (FDA). Clinuvel can now commence clinical trials in the US, the world's largest pharmaceutical market.

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FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications
The U.S. Food and Drug Administration today announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality).

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>Implanon ran out early? (Handbag.com)
Implanon ran out early? Can someone pls give me some advice? I got implanon abt 2 1/2yrs ago & read somewhere that if you're overweight it may not last the full 3 years.

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COBAS TaqMan HCV Test For Use With the COBAS AmpliPrep Instrument and the COBAS TaqMan Analyzer or the COBAS TaqMan 48 Analyzer
This laboratory test measures the amount of hepatitis C viral RNA in a patient?s blood. Viral RNA (ribonucleic acid) is genetic material from the hepatitis C virus. (Approved: 10/30/2008)

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Peanut Corporation of America Announces Voluntary Nationwide Recall of Peanut Butter (January 13)
Peanut Corporation of America (PCA), a peanut processing company and maker of peanut butter for bulk distribution to institutions, food service industries, and private label food companies, today announced a voluntary recall of peanut butter produced in its Blakely, Georgia processing facility because it has the potential to be contaminated with Salmonella.

South Bend Chocolate Company Recalls Various Candys Containing Peanut Butter Because of Possible Salmonella Contamination (January 18)
The South Bend Chocolate Company today announced a voluntary recall of certain candy products because they contain peanut butter from Peanut Corporation of America, which may be contaminated with Salmonella.

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FDA Proposes Label Requirements for Refused Imported Foods
The U.S. Food and Drug Administration today issued a proposed rule designed to reduce a practice known as "port shopping" which puts the safety of imported food at risk.

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FDA Prevents Two Dairies from Adulterating Animal Drugs and Food
The U.S. Food and Drug Administration announced today that the District Court for the District of New Mexico has enjoined Do-Rene and Clover Knolls Dairies and their owners, Douglas B. Handley and Irene Handley, from adulterating new animal drugs and introducing adulterated food into commerce. Both companies are based in Clovis, N.M.

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In peanut checks, gaps for salmonella to sneak by (Detroit Free Press)
ATLANTA -- Food regulators didn't consider salmonella a threat to most peanut products before they traced an outbreak to a peanut butter plant in Georgia two years ago. Officials in the nation's top peanut-producing state promptly began checking for the bacteria during routine inspections, and everything went fine for about a year.

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Les Weisbrod: Big Pharma Won't Police Itself (HuffingtonPost)
"FDA Criticized on Device Approvals" "FDA Is Lax on Oversight During Trials, Inquiry Finds" "In FDA Files, Claims of Rush to Approve Devices" "Financial Disclosures...

Mylan Receives Final FDA Approvals for Generic Versions of Lamictal(R) Tablets and Lamictal(R) CD (PR Newswire via Yahoo! Finance)
Mylan Inc. today announced that its subsidiaries Mylan Pharmaceuticals Inc. and Genpharm ULC received final approvals from the U.S. Food and Drug Administration for their Abbreviated New Drug Applications for Lamotrigine Tablets.

Study: Adding Vimpat significantly reduces partial-onset seizures in adults with epilepsy (EurekAlert!)
( Cooney Waters Group, Inc. ) Vimpat demonstrated greater seizure reduction and improved seizure freedom versus placebo when added to first and second-generation antiepileptic drugs. A phase III study supports recent US FDA and European Commission approvals of Vimpat.

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OPKO Receives FDA 510(k) Clearance For Spectral OCT SLO Combination Imaging System (Medical News Today)
OPKO Health, Inc. (NYSE Alternext US:OPK) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") to begin marketing in the United States its Spectral OCT SLO Combination Imaging System.

Sirion Therapeutics New Drug Application For Ganciclovir Is Accepted For Review By The FDA For The Treatment Of Ocular ... (Medical News Today)
Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced that its New Drug Application (NDA) for ganciclovir ophthalmic gel, 0.15%, has been accepted for review by the U.S. Food and Drug Administration (FDA). Sirion Therapeutics is seeking approval for ganciclovir as a treatment for herpetic keratitis, an ocular disease caused by the herpes simplex virus.

Geron Receives FDA Clearance To Begin World's First Human Clinical Trial Of Embryonic Stem Cell-Based Therapy (Medical News Today)
Geron Corporation (Nasdaq:GERN) announced that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury. The clearance enables Geron to move forward with the world's first study of a human embryonic stem cell (hESC)-based therapy in man.

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FDA Requires New Safety Measures for Oral Sodium Phosphate Products to Reduce Risk of Acute Kidney Injury
Today, the U.S. Food and Drug Administration announced that it will add a Boxed Warning to the prescription oral sodium phosphate products Visicol and OsmoPrep to warn consumers about the risk of acute phosphate nephropathy (a type of acute kidney injury). Patients routinely take OSP products to cleanse the bowel before a colonoscopy (colon examination) and other medical procedures.

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FDA Alerts Public about Danger of Skin Numbing Products
The U.S. Food and Drug Administration today issued a Public Health Advisory to alert consumers, patients, health care professionals, and caregivers about potentially serious and life-threatening side effects from the improper use of skin numbing products. The products, also known as topical anesthetics, are available in over-the-counter (OTC) and prescription forms.

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Geron Receives FDA Clearance To Begin World's First Human Clinical Trial Of Embryonic Stem Cell-Based Therapy (Medical News Today)
Geron Corporation (Nasdaq:GERN) announced that the U.S. Food and Drug Administration (FDA) has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury. The clearance enables Geron to move forward with the world's first study of a human embryonic stem cell (hESC)-based therapy in man.

OPKO Receives FDA 510(k) Clearance For Spectral OCT SLO Combination Imaging System (Medical News Today)
OPKO Health, Inc. (NYSE Alternext US:OPK) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") to begin marketing in the United States its Spectral OCT SLO Combination Imaging System.

Which One of These Is Not Like the Other? (The Motley Fool)
Bristol-Myers and Eli Lilly run into some comparability issues.

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ICON Delivers New Electronic Solution to Expedite Clinical Trial Adjudication (PR Newswire via Yahoo! Finance)
ICON plc, , a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced the launch of a new electronic solution that will accelerate the adjudication of cardiovascular events in diabetes studies.

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FDA Announces Participants of Pilot Program for Third-Party Certification of Imported Aquacultured Shrimp
The U.S. Food and Drug Administration today announced the participants in Phase II of its pilot program for voluntary third-party certification programs for imported aquacultured shrimp.

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