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EFSA and FDA Strengthen Cooperation in Food Safety Science The


EFSA and FDA Strengthen Cooperation in Food Safety Science
The European Food Safety Authority (EFSA) and the U.S. Food and Drug Administration (FDA) today signed the first U.S./European agreement in the area of assessing food safety risk.

FDA Approvals - St. Jude Medical Receives FDA Clearance For ACross Transseptal Access


St. Jude Medical Receives FDA Clearance For ACross Transseptal Access System (Medical News Today)
St. Jude Medical, Inc. (NYSE:STJ) announced U.S. Food and Drug Administration (FDA) clearance and a Health Canada License for the ACross(TM) Transseptal Access System, a device that improves control and simplifies the procedure physicians use to access the left atrium during complex cardiac procedures such as atrial fibrillation ablation. [click link for full article]

St. Jude Medical Announces FDA Clearance Of The Proxis Embolic Protection System (Medical News Today)
St. Jude Medical, Inc., (NYSE:STJ) announced U.S. Food and Drug Administration (FDA) clearance of the 7F Proxis(TM) Embolic Protection System. [click link for full article]

FDA sued over Provenge delay (Seattle Times)
The heated controversy over Dendreon's prostate-cancer drug Provenge has boiled over into the courtroom. A patient-advocacy group sued U...

Update on Tainted Veggie Booty Snack Food The Food and


Update on Tainted Veggie Booty Snack Food
The Food and Drug Administration (FDA) today confirmed a strain of Salmonella Wandsworth bacteria found in Veggie Booty snack food, is responsible for the disease outbreak that occurred between March and June 2007.

Argentis taking steps toward FDA review (BizJournals) Argentis Pharmaceuticals LLC


Argentis taking steps toward FDA review (BizJournals)
Argentis Pharmaceuticals LLC has selected Target Health Inc. for its upcoming clinical trials, which brings the Memphis startup one step closer to FDA review.

Akorn Announces Development and Supply Agreement with Hyaluron For Two Injectable ANDA Suspension Drug Products (Business Wire via Yahoo! Finance)
BUFFALO GROVE, Ill.----Akorn, Inc. today announced the signing of a development and supply agreement with Hyaluron Contract Manufacturing, Inc. , an innovative leader in aseptic formulation and filling of liquid parenterals located in Burlington, Massachusetts.

FDA Approvals - Strides Arcolab's net surges by 111% to Rs 11.58 in


Strides Arcolab's net surges by 111% to Rs 11.58 in Q2 (PharmaBiz)
Strides Arcolab has notched up impressive growth in bottom line during the second quarter ended June 2007. Its consolidated net profit went up sharply by 111 per cent to Rs 11.58 crore from Rs 5.50 crore in the corresponding quarter of last year.

AspenBio Pharma Advances BoviPure FSH(TM) Reproduction Drug with FDA Filing and GMP Manufacturing Contract (PR Newswire via Yahoo! Finance)
AspenBio Pharma, Inc. an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for animals and humans, today reported that it has received its INADA file number for BoviPure FSH to officially start the United States Food and Drug Administration approval process.

FDA Detains Imports of Farm-Raised Chinese Seafood This action by


FDA Detains Imports of Farm-Raised Chinese Seafood
This action by FDA, a part of the U.S. Department of Health and Human Services, will protect American consumers from unsafe residues that have been detected in these products. There have been no reports of illnesses to date.

Review of subdermal implantable contraceptives (News-Medical-Net) A Cochrane Systematic Review


Review of subdermal implantable contraceptives (News-Medical-Net)
A Cochrane Systematic Review that set out to assess the effectiveness and tolerability of subdermal implantable contraceptives compared to other reversible methods of contraception found that they were all good at preventing pregnancy.

FDA Warns Consumers Not to Eat Veggie Booty Snack Food


FDA Warns Consumers Not to Eat Veggie Booty Snack Food
The U.S. Food and Drug Administration is warning consumers not to eat Veggie Booty snack food, marketed by Robert's American Gourmet, due to possible contamination with Salmonella Wandsworth bacteria that cause gastrointestinal illness.

C-flex? intraocular lens C-flex? is a plastic lens used to


C-flex? intraocular lens
C-flex? is a plastic lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. A cataract is a gradual thickening, hardening and clouding of the eye's lens, resulting in loss of vision. Cataracts... (Approved: 5/3/2007)

Nissin Foods (USA) Co., Inc. Issues Allergy Alert for Cod


Nissin Foods (USA) Co., Inc. Issues Allergy Alert for Cod and Lobster in Certain Noodle Products (July 20)
Nissin Foods (USA) Co., Inc. announced a voluntary nationwide recall of selected shrimp-flavored noodle products as a safety precaution after it was discovered that the seafood-flavored powder used in these Nissin products also contains cod and lobster.

Wellbaskets.com Is Alerting Customers of the Veggie Booty Voluntary Recall Issued on June 28, 2007 by Robert's American Gourmet (July 2)
Veggie Booty has been voluntarily recalled by manufacturer Robert's American Gourmet due to possible Salmonella contamination. The recently recalled product, Veggie Booty, was a component of many gift baskets created by www.wellbaskets.com.

California Department of Public Health Announces San Diego Botulism Case (July 27)
The San Diego County Health and Human Services Agency and CDPH are investigating whether the woman's illness is associated with Castleberry Food canned products that were recently recalled due to possible contamination with the toxin that causes botulism. The woman reported purchasing and eating one of the products, Kroger Chili with Beans, prior to her illness in early July.

FDA Approvals - AspenBio Pharma Advances BoviPure FSH(TM) Reproduction Drug with FDA Filing


AspenBio Pharma Advances BoviPure FSH(TM) Reproduction Drug with FDA Filing and GMP Manufacturing Contract (PR Newswire via Yahoo! Finance)
AspenBio Pharma, Inc. an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for animals and humans, today reported that it has received its INADA file number for BoviPure FSH to officially start the United States Food and Drug Administration approval process.

St. Jude Medical Receives FDA Clearance for ACross Transseptal Access System (Business Wire via Yahoo! Finance)
ST. PAUL, Minn.----St. Jude Medical, Inc. today announced U.S. Food and Drug Administration clearance and a Health Canada License for the ACross Transseptal Access System, a device that improves control and simplifies the procedure physicians use to access the left atrium during complex cardiac procedures such as atrial fibrillation ablation.

St. Jude Medical Announces FDA Clearance of the Proxis Embolic Protection System (FinanzNachrichten)
St. Jude Medical, ( Nachrichten ) Inc., (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) clearance of the 7F Proxis Embolic Protection System.

FDA Warns Consumers about Risk of Botulism Poisoning from Hot


FDA Warns Consumers about Risk of Botulism Poisoning from Hot Dog Chili Sauce Marketed Under a Variety of Brand Names
The U.S. Food and Drug Administration (FDA) is warning consumers not to eat 10 ounce cans of Castleberry's Hot Dog Chili Sauce (UPC 3030000101), Austex Hot Dog Chili Sauce (UPC 3030099533), and Kroger Hot Dog Chili Sauce (UPC 1111083942) with "best by" dates from April 30, 2009 through May 22, 2009 due to possible botulism contamination.

Wyeth Receives Approvable Letter from FDA for PRISTIQ for the


Wyeth Receives Approvable Letter from FDA for PRISTIQ for the Treatment of Vasomotor Symptoms Associated with Menopause (The San Francisco Examiner)
COLLEGEVILLE, Pa. ( Map ) - Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), announced today that it received an approvable letter from the U.S. Food and Drug Administration (FDA) for PRISTIQ(TM) (desvenlafaxine), a serotonin-norepinephrine reuptake inhibitor (SNRI), currently under review as a treatment for moderate-to-severe vasomotor symptoms (hot flashes and night sweats) associated ...

FDA Approvals - AspenBio Pharma Advances BoviPure FSH(TM) Reproduction Drug with FDA Filing


AspenBio Pharma Advances BoviPure FSH(TM) Reproduction Drug with FDA Filing and GMP Manufacturing Contract (PR Newswire via Yahoo! Finance)
AspenBio Pharma, Inc. an emerging bio-pharmaceutical company dedicated to the development of novel drugs and diagnostics for animals and humans, today reported that it has received its INADA file number for BoviPure FSH to officially start the United States Food and Drug Administration approval process.

Anika Therapeutics Receives FDA Approval for ELEVESS(TM) Product (Business Wire via Yahoo! Finance)
WOBURN, Mass.----Anika Therapeutics, Inc. today announced that it has received U.S. FDA approval for commercial sale of its corrective and aesthetic dermatology product. This product is licensed to Galderma Pharma, S.A. who will launch it worldwide under its proprietary brand name, ELEVESS.

FDA Approves CustomVue Monovision LASIK The U.S. Food and Drug


FDA Approves CustomVue Monovision LASIK
The U.S. Food and Drug Administration approved for marketing the first LASIK device designed for treating one eye to see far away objects and the other eye for close-up vision.

FDA Approvals - St. Jude Medical Receives FDA Clearance for ACross Transseptal Access


St. Jude Medical Receives FDA Clearance for ACross Transseptal Access System (Business Wire via Yahoo! Finance)
ST. PAUL, Minn.----St. Jude Medical, Inc. today announced U.S. Food and Drug Administration clearance and a Health Canada License for the ACross Transseptal Access System, a device that improves control and simplifies the procedure physicians use to access the left atrium during complex cardiac procedures such as atrial fibrillation ablation.

Oncolytics Biotech Inc. Announces 2007 Second Quarter Results (PR Newswire via Yahoo! Finance)
Oncolytics Biotech Inc. today announced its financial results and highlights for the three and six-month periods ended June 30, 2007.

St. Jude Medical Announces FDA Clearance of the Proxis Embolic Protection System (FinanzNachrichten)
St. Jude Medical, ( Nachrichten ) Inc., (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) clearance of the 7F Proxis Embolic Protection System.

FDA Nanotechnology Report Outlines Scientific, Regulatory Challenges FDA's Nanotechnology Task


FDA Nanotechnology Report Outlines Scientific, Regulatory Challenges
FDA's Nanotechnology Task Force today released a report that recommends the agency consider developing guidance and taking other steps to address the benefits and risks of drugs and medical devices using nanotechnology.

FDA Detains Imports of Farm-Raised Chinese Seafood This action by


FDA Detains Imports of Farm-Raised Chinese Seafood
This action by FDA, a part of the U.S. Department of Health and Human Services, will protect American consumers from unsafe residues that have been detected in these products. There have been no reports of illnesses to date.

Study: Implantable Contraceptives Work (MedicineNet.com) Title: Study: Implantable Contraceptives Work


Study: Implantable Contraceptives Work (MedicineNet.com)
Title: Study: Implantable Contraceptives Work Category: Health News Created: 7/19/2007 Last Editorial Review: 7/19/2007

Wyeth Receives Approvable Letter from FDA for PRISTIQ for the


Wyeth Receives Approvable Letter from FDA for PRISTIQ for the Treatment of Vasomotor Symptoms Associated with Menopause (The San Francisco Examiner)
COLLEGEVILLE, Pa. ( Map ) - Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), announced today that it received an approvable letter from the U.S. Food and Drug Administration (FDA) for PRISTIQ(TM) (desvenlafaxine), a serotonin-norepinephrine reuptake inhibitor (SNRI), currently under review as a treatment for moderate-to-severe vasomotor symptoms (hot flashes and night sweats) associated ...

Wyeth Receives Approvable Letter From FDA for PRISTIQ for the Treatment of Vasomotor Symptoms Associated With Menopause (PRWeb via Yahoo! News)
Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), announced today that it received an approvable letter from the U.S. Food and Drug Administration (FDA) for PRISTIQ (desvenlafaxine), a serotonin-norepinephrine reuptake inhibitor (SNRI), currently under review as a treatment for moderate-to-severe vasomotor symptoms (hot flashes and night sweats) associated with menopause.
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