Orbis Clinical Meets Growing Demands of Intensified FDA Regulations (Business Wire via Yahoo! Finance)
WOBURN, Mass.----Orbis Clinical has announced that it has completed its move to Woburn, Massachusetts. The firm, which is dedicated to providing today's hottest biotechnology and pharmaceutical companies with the human resources, strategy, education and expertise required to effectively launch a drug in today's safety-conscious world, employs medical professionals around the globe.

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Anika Therapeutics Receives FDA Approvable Letter For Its Cosmetic Tissue Augmentation Product (Medical News Today)
Anika Therapeutics, Inc. (Nasdaq: ANIK) today announced that it has received an FDA approvable letter for its cosmetic tissue augmentation ("CTA") product. CTA is an injectable soft tissue filler for facial wrinkles, scar remediation and lip augmentation. [click link for full article]

Abraxis BioScience Receives FDA Approval for Ampicillin and Sulbactam for Injection, 15g, USP (Business Wire via Yahoo! Finance)
LOS ANGELES----Abraxis BioScience, Inc. , an integrated, global biopharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for the combination drug Ampicillin and Sulbactam for Injection, 15g, USP, the generic equivalent of Pfizer Inc.'s Unasyn .

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St. Jude Medical Announces FDA Approval of Optim Lead Insulation for Cardiac Rhythm Management Therapy (Business Wire via Yahoo! Finance)
ST. PAUL, Minn.----St. Jude Medical, Inc. today announced U.S. Food and Drug Administration approval of an innovative insulation material for cardiac leads used with pacemakers and implantable cardioverter defibrillators .

Anika Therapeutics Receives FDA Approvable Letter For Its Cosmetic Tissue Augmentation Product (Medical News Today)
Anika Therapeutics, Inc. (Nasdaq: ANIK) today announced that it has received an FDA approvable letter for its cosmetic tissue augmentation ("CTA") product. CTA is an injectable soft tissue filler for facial wrinkles, scar remediation and lip augmentation. [click link for full article]

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FDA Invites Input on Electronic Submission of Regulatory Information
The Public Hearing will Focus on Transforming to an All-Electronic Environment

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Chembio Receives CLIA Waiver for HIV 1/2 STAT-PAK(TM) (Business Wire via Yahoo! Finance)
MEDFORD, N.Y.----Chembio Diagnostics Inc. has received CLIA Waiver for one of its two FDA-approved rapid HIV tests, HIV 1/2 STAT-PAK. The CLIA waiver allows Chembio to market these HIV tests to a potential market of approximately 189,000 laboratory entities across the United States, including doctors' offices and clinics.

FDA Accepts as ``Complete Response'' Oscient Pharmaceuticals' Submission Following FACTIVE Approvable Letter for (Business Wire via Yahoo! Finance)
WALTHAM, Mass.----The U.S. Food and Drug Administration has accepted as complete Oscient Pharmaceuticals Corporation's response to the FACTIVE tablets approvable letter for the application seeking approval for the five-day treatment of community-acquired pneumonia of mild to moderate severity .

Barr's Subsidiary PLIVA Receives Approval for Pravastatin Tablets 10mg, 20mg, and 40mg and Tentative Approval for 80mg (FinanzNachrichten)
WOODCLIFF LAKE, N.J., Nov. 28 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, ( Nachrichten ) Inc. and its subsidiary PLIVA ( Nachrichten ) d.d. ( ZSE: PLVA-R-A) today announced that PLIVA has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market Pravastatin Tablets 10mg, 20mg, and 40mg, the generic

Read more about FDA Approvals - Chembio Receives CLIA Waiver for HIV 1/2 STAT-PAK(TM) (Business Wire

STAAR Surgical Provides Update on Toric ICL Application with FDA (PR Newswire via Yahoo! Finance)
STAAR Surgical Company today provided an update on the status of the Company's submission to the U.S. Food and Drug Administration for approval of its Visian TICL, a toric implantable Collamer lens designed to treat both nearsightedness and astigmatism.

FDA fines American Red Cross $5.7 million for blood violations (USA Today)
The federal government has fined the American Red Cross $5.7 million for violating blood-safety laws and the terms of a 2003 consent decree.

Orbis Clinical Meets Growing Demands of Intensified FDA Regulations (Business Wire via Yahoo! Finance)
WOBURN, Mass.----Orbis Clinical has announced that it has completed its move to Woburn, Massachusetts. The firm, which is dedicated to providing today's hottest biotechnology and pharmaceutical companies with the human resources, strategy, education and expertise required to effectively launch a drug in today's safety-conscious world, employs medical professionals around the globe.

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FDA Reminds Consumers of Serious Risks of Using Decorative Contact Lenses without Consulting Eye Care Professional
This Halloween season, the U.S. Food and Drug Administration (FDA) is again warning consumers about the serious risks of using decorative contact lenses without the appropriate involvement of an eye care professional.

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Matlock OB/GYN Offers New Three-Year Birth Control Implant (RedNova)
The physicians at Matlock OB/GYN, with offices in Arlington and Mansfield, Texas, are now offering Implanon, a new matchstick-size implantable contraceptive that is effective for up to three years.

Implantable Birth Control New Option For Women (Science Daily)
A single-rod implantable contraceptive that has been available in other countries since 1998 is now being used in the United States, including in the Cincinnati area. The implant is injected underneath the skin of the upper arm during an in-office procedure that takes about one minute. The implant, the size of a matchstick, releases a steady stream of the female hormone etonogestrel (Implanon)

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Zilver Vascular Stent
The Zilver Vascular Stent is a thin, flexible metal mesh tube that can be implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries). The Zilver stent acts like a scaffold by holding an iliac artery open to maintain adequate (Approved: 6/26/2006)

Read more about Zilver Vascular Stent The Zilver Vascular Stent is a thin,

Krisp-Pak Company, Inc. Recalls Fresh Cut Fruit Because of Possible Health Risk
The recalled fresh cut fruit was distributed in the Hampton Roads and Richmond, VA areas and the Charlotte, Greensboro and Raleigh, NC areas through retail stores and foodservice distribution centers.

Rio Vista, Ltd. Recalls Cantaloupes Nationwide Because of Possible Health Risk
Approximately, 62,640 cartons of cantaloupes were distributed in the U.S. and a small quantity went to Canada from October 31 to November 6, 2006. The cantaloupes were distributed for sale in bulk in cardboard cartons containing from 6 to 15 cantaloupes to a carton.

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US FDA approves generic ondansetron injection (PharmaBiz)
The US Food and Drug Administration (FDA) approved first generic versions of Zofran (Ondansetron) injection and Zofran (Ondansetron) injection Premixed.

Affymetrix 500K Array Used to Generate First Copy Number Variation Map of the Human Genome (RedNova)
Affymetrix Inc. (NASDAQ:AFFX) announced today t

Read more about FDA Approvals - US FDA approves generic ondansetron injection (PharmaBiz) The US Food

Fougera gets US FDA nod for generic Sulfacetamide Sodium (PharmaBiz)
Specialty pharmaceutical manufacturer Fougera, a division of Altana Inc, announced has received FDA approval to bring to market the first generic Sulfacetamide Sodium Topical Suspension USP 10 per cent. The generic formulation compares to Klaron by Dermik, whose patent has expired.

Repligen Receives Orphan Drug Designation From The FDA For RG1068 For MRI Imaging Of The Pancreas (Medical News Today)
Repligen Corporation (Nasdaq: RGEN) announced today that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) granted orphan drug designation to RG1068, synthetic human secretin, for use with magnetic resonance imaging (MRI) of the pancreas. [click link for full article]

Read more about FDA Approvals - Fougera gets US FDA nod for generic Sulfacetamide Sodium (PharmaBiz)

FDA Announces Actions to Strengthen its Postmarket Program for Medical Devices
The U.S. Food and Drug Administration (FDA) has announced its action plan for strengthening the way it monitors the safety of medical devices after they reach the marketplace.

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AssurX Announces OnDemand PreConfigured Quality Management And Regulatory Compliance Solutions (ChemicalOnline)
AssurX, Inc. has announced the release of its new CATSWeb PreConfigured Quality Management and Regulatory Compliance Solutions offered as a Software-as-a-Service (SaaS) software delivery model, providing organizations with an alternative easy-to-use, secure, and reliable enterprise quality solution that is accessed over the Internet for a low flexible fee

FDA approves silicone gel-filled breast implants (News-Medical-Net)
After rigorous scientific review, the U.S. Food and Drug Administration (FDA) has approved the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older.

Ortho-Clinical Diagnostics Receives FDA Approval For Bio-Rad's Genetic Systems HIV-1/HIV-2 PLUS O EIA On The Ortho (Medical News Today)
Ortho-Clinical Diagnostics, a Johnson & Johnson company, announced today that the Food and Drug Administration (FDA) has approved Bio-Rad Laboratories Inc.'s Genetic Systems HIV-1/HIV-2 PLUS O EIA for use on The Ortho Summit System. [click link for full article]

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Fougera gets US FDA nod for generic Sulfacetamide Sodium (PharmaBiz)
Specialty pharmaceutical manufacturer Fougera, a division of Altana Inc, announced has received FDA approval to bring to market the first generic Sulfacetamide Sodium Topical Suspension USP 10 per cent. The generic formulation compares to Klaron by Dermik, whose patent has expired.

FDA Accepts DOR BioPharma's NDA Filing for orBec(R) (Market Wire via Yahoo! Finance)
DOR BioPharma, Inc. announced today that the U.S. Food and Drug Administration ("FDA") has accepted the Company's New Drug Application for orBec for the treatment of gastrointestinal Graft-versus-Host disease. The FDA has granted the orBec NDA application a standard review designation and established a target action date of July 21, 2007 for completion of review of the NDA in accordance with

Read more about FDA Approvals - Fougera gets US FDA nod for generic Sulfacetamide Sodium (PharmaBiz)

FDA Invites Input on Electronic Submission of Regulatory Information
The Public Hearing will Focus on Transforming to an All-Electronic Environment

Read more about FDA Invites Input on Electronic Submission of Regulatory Information The

Implantable Birth Control New Option For Women (Science Daily)
A single-rod implantable contraceptive that has been available in other countries since 1998 is now being used in the United States, including in the Cincinnati area. The implant is injected underneath the skin of the upper arm during an in-office procedure that takes about one minute. The implant, the size of a matchstick, releases a steady stream of the female hormone etonogestrel (Implanon)

Matlock OB/GYN Offers New Three-Year Birth Control Implant (RedNova)
The physicians at Matlock OB/GYN, with offices in Arlington and Mansfield, Texas, are now offering Implanon, a new matchstick-size implantable contraceptive that is effective for up to three years.

Read more about Implantable Birth Control New Option For Women (Science Daily) A

FDA Approves First Generic Ondansetron Injection (Kansas City InfoZine)
The U. S. Food and Drug Administration (FDA) today approved first generic versions of Zofran (Ondansetron) Injection and Zofran (Ondansetron) Injection Premixed.

Drugmakers' payments to FDA for reviews to increase by 29% (Chicago Tribune)
Drugmakers have agreed to a nearly 29 percent increase in payments to federal regulators to ensure speedy approvals of new medicines and step up safety monitoring, a person familiar with the deal said Tuesday.

IDMA conducts pharma analysts' meet (PharmaBiz)
The Indian Drug Manufactures Association (IDMA) held tenth Pharmaceutical Analysts Conversation (PAC) 2006, recently at Mumbai. The theme of the meet was US FDA approvals for Indian pharma firms.

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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

Rio Vista, Ltd. Recalls Cantaloupes Nationwide Because of Possible Health Risk
Approximately, 62,640 cartons of cantaloupes were distributed in the U.S. and a small quantity went to Canada from October 31 to November 6, 2006. The cantaloupes were distributed for sale in bulk in cardboard cartons containing from 6 to 15 cantaloupes to a carton.

Advanced Medical Optics Announces Voluntary Recall of 18 Lots of Complete MoisturePLUS Contact Lens Care Products Distributed and Sold in the U.S.
Contact lens users who experience symptoms of an eye infection such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling, should remove their lenses and consult their eye care provider immediately.

Read more about Rio Vista, Ltd. Recalls Cantaloupes Nationwide Because of Possible Health