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FDA to check safety of imported Chinese seafood (Reuters via


FDA to check safety of imported Chinese seafood (Reuters via Yahoo! News)
The Food and Drug Administration said on Thursday it will detain imports of Chinese farm-raised catfish, shrimp and other seafood to make sure the shipments are free from harmful residues.

FDA says Chinese fish tainted (Los Angeles Times)
Five types of seafood join a growing list of questionable products from that country. Imports are blocked. WASHINGTON The list of quality-compromised goods from China got longer Thursday as federal authorities slapped a highly unusual hold on shrimp and certain fish from that country after tests showed contamination from potentially harmful drugs.

FDA Approvals - Taxotere(R) (docetaxel) Granted FDA Priority Review For Treatment Of Locally


Taxotere(R) (docetaxel) Granted FDA Priority Review For Treatment Of Locally Advanced Squamous Cell Carcinoma Of The ... (Medical News Today)
Sanofi-aventis announced today that the U.S. [click link for full article]

Priority review for Taxotere in head and neck cancer (PharmaBiz)
Sanofi-aventis announced that the US Food and Drug Administration (FDA) has accepted for filing and assigned priority review status to the supplemental new drug application (sNDA) for Taxotere (docetaxel) Injection Concentrate in combination with cisplatin and fluorouracil for the induction (neo-adjuvant) therapy of patients with locally advanced squamous cell carcinoma of the head and neck ...

FDA Releases Human Tissue Task Force Report The report was


FDA Releases Human Tissue Task Force Report
The report was issued by FDA's Human Tissue Task Force (HTTF), an intra-agency group assembled in August 2006 to evaluate the effectiveness of FDA's tissue regulations.

Business notes (Concord Monitor) The Northeast Resource Recovery Association, a


Business notes (Concord Monitor)
The Northeast Resource Recovery Association, a non-profit recycling cooperative, was presented with the 2006 Environmental Stewardship Award from Veolia Technical Solutions of North America. NRRA was selected because of its mission to the environment through waste reduction, recycling and education.

FDA Issues Dietary Supplements Final Rule The rule ensures that


FDA Issues Dietary Supplements Final Rule
The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.

Radiesse (P050052) Radiesse is an injectable calcium hydroxylapatite implant in


Radiesse (P050052)
Radiesse is an injectable calcium hydroxylapatite implant in the form of a gel. (Approved: 12/22/2006)

A. Bazzini Co. Inc. Issues an Alert on Undeclared Sulfites


A. Bazzini Co. Inc. Issues an Alert on Undeclared Sulfites in Dried Turkish Jumbo Apricots (June 11)
The product was distributed in 4.25lb plastic containers (jars) during the month of March 2007 with the following lot number: 7064.

WholeSoy and Co. Expands National Allergy Alert on Undeclared Dairy in Blueberry and Mixed Berry Yogurt (June 12)
The affected batches of Blueberry yogurt have "best by" date of June 22 and "best by" date of June 29. The UPC code is 664372600086. The affected batches of Mixed Berry yogurt have "best by" date of June 22 and "best by" date of June 29. The UPC code is 664372600222.

Tristar Food Recalls Ferrari Chocolate Due to Undeclared Peanuts and Aflatoxins (June 6)
The recalled Ferrari Chocolates, a product of China, is distributed in 280g and 240g per box. The Ferrari chocolate was sold in New York City and in New Jersey.

FDA Approvals - DOR Appoints Cyrille F. Buhrman to Its Board of Directors


DOR Appoints Cyrille F. Buhrman to Its Board of Directors (Market Wire via Yahoo! Finance)
DOR BioPharma, Inc., a biopharmaceutical company addressing life-threatening side effects of cancer and cancer treatments, serious gastrointestinal diseases and disorders, and biodefense countermeasures, today announced the appointment of Cyrille F.

Advancis Pharmaceutical Reports on Meeting With FDA Reviewing Keflex PULSYS Phase III Trial Design (RedNova)
GERMANTOWN, Md., June 26 /PRNewswire-FirstCall/ -- Advancis Pharmaceutical Corporation , a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced it has concluded a Pre-Phase III meeting with the U.S.

Taxotere(R) (docetaxel) Granted FDA Priority Review for Treatment of Locally Advanced Squamous Cell Carcinoma of the ... (PR Newswire via Yahoo! Finance)
Sanofi-aventis announced today that the U.S. Food and Drug Administration has accepted for filing and assigned priority review status to the supplemental new drug application for Taxotere Injection Concentrate in combination with cisplatin and fluorouracil for the induction therapy of patients with locally advanced squamous cell carcinoma of the head and neck prior to chemoradiotherapy and ...

FDA Releases New Software Tool to Help Keep Food Facilities


FDA Releases New Software Tool to Help Keep Food Facilities Safe from Attack
FDA released a new tool to help growers, packers, processors, manufacturers, warehousers, transporters, and retailers in the food industry determine the vulnerability of individual food facilities to biological, chemical, or radiological attack.

Cerner Receives FDA Clearance for Cerner Bridge Transfusion Administration and


Cerner Receives FDA Clearance for Cerner Bridge Transfusion Administration and Specimen Collections (Business Wire via Yahoo! Finance)
KANSAS CITY, Mo.----Cerner Corp. announced today that Cerner Bridge Transfusion Administration and Specimen Collections software solution has received U.S. Food and Drug Administration 510 pre-market notification clearance.

FDA Approvals - Priority review for Taxotere in head and neck cancer (PharmaBiz)


Priority review for Taxotere in head and neck cancer (PharmaBiz)
Sanofi-aventis announced that the US Food and Drug Administration (FDA) has accepted for filing and assigned priority review status to the supplemental new drug application (sNDA) for Taxotere (docetaxel) Injection Concentrate in combination with cisplatin and fluorouracil for the induction (neo-adjuvant) therapy of patients with locally advanced squamous cell carcinoma of the head and neck ...

Taxotere(R) (docetaxel) Granted FDA Priority Review For Treatment Of Locally Advanced Squamous Cell Carcinoma Of The ... (Medical News Today)
Sanofi-aventis announced today that the U.S. [click link for full article]

Natco gets US FDA approval for ondansetron tabs (PharmaBiz)
Natco Pharma Ltd has informed that the company's application for abbreviated new drug (ANDA) for ondansetron hydrochloride tablets in multiple strengths 4 mg and 8 mg has been approved by the US Food and Drug Administration.

FDA Approves First Drug for Treating Fibromyalgia The U.S. Food


FDA Approves First Drug for Treating Fibromyalgia
The U.S. Food and Drug Administration has approved Lyrica (pregabalin), the first drug to treat fibromyalgia, a disorder characterized by pain, fatigue and sleep problems.

FDA Approvals - OXiGENE Adds Two New Directors to Its Board (Stock World)


OXiGENE Adds Two New Directors to Its Board (Stock World)
OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that the Company has added two new members to its Board of Directors.

Advancis Pharmaceutical Reports on Meeting With FDA Reviewing Keflex PULSYS Phase III Trial Design (RedNova)
GERMANTOWN, Md., June 26 /PRNewswire-FirstCall/ -- Advancis Pharmaceutical Corporation , a pharmaceutical company focused on developing and commercializing novel anti-infective products, today announced it has concluded a Pre-Phase III meeting with the U.S.

Regulatory Cooperation Expanded The US Food and Drug Administration (FDA),


Regulatory Cooperation Expanded
The US Food and Drug Administration (FDA), the European Commission (EC), and the European Medicines Agency (EMEA) have agreed to expand their current cooperative activities in several important areas.

FDA Clears 'Computerized Medication Box' for U.S. Market The U.S.


FDA Clears 'Computerized Medication Box' for U.S. Market
The U.S. Food and Drug Administration has cleared for marketing the INRange Systems' Electronic Medication Management Assistant (EMMA), a programmable device that stores and dispenses prescription medication for patients' use in the home.

Business notes (Concord Monitor) The Northeast Resource Recovery Association, a


Business notes (Concord Monitor)
The Northeast Resource Recovery Association, a non-profit recycling cooperative, was presented with the 2006 Environmental Stewardship Award from Veolia Technical Solutions of North America. NRRA was selected because of its mission to the environment through waste reduction, recycling and education.

FDA Approvals - Cytomedix Announces CMS to Reconsider Coverage for Platelet Rich Plasma


Cytomedix Announces CMS to Reconsider Coverage for Platelet Rich Plasma Technology (PrimeNewswire via Yahoo! Finance)
ROCKVILLE, Md., June 26, 2007 -- Cytomedix, Inc. today announced that the Centers for Medicare and Medicaid Services has agreed to Cytomedix's request to reconsider a non-coverage decision for autologous blood-derived products when used for the treatment of chronic non-healing wounds.

Health Canada Approves ADVR's Application for Clinical IND (RedNova)
Advanced Viral Research Corp. (OTCBB: ADVR), a

Safety And Statistically Significant Improvement In Parkinson's Disease Shown By Gene Therapy Study (Medical News Today)
Neurologix, Inc. (OTC Bulletin Board: NRGX) has announced in the journal The Lancet publication of positive results from the first ever gene therapy trial for Parkinson's disease and the first report of direct gene transfer into a patient's own brain cells for any adult neurodegenerative disease. [click link for full article]

Shelhigh Enters Consent Order with FDA (U. S. Food and


Shelhigh Enters Consent Order with FDA (U. S. Food and Drug Administration)
Under a court order signed June 22, 2007, Shelhigh, Inc., of Union, N.J., agreed to stop distributing its implantable medical devices, used in heart surgery and other procedures, until the company brings its production processes in line with FDA standards.

King Pharmaceuticals And Palatin Technologies Announce End-of-Phase 2 Meeting With FDA For Bremelanotide (Medical News Today)
Palatin Technologies, Inc. (Amex: PTN) and King Pharmaceuticals, Inc. (NYSE: KG) announced today that the U.S. Food and Drug Administration (FDA) has scheduled an End-of-Phase 2 meeting to discuss clinical study results with bremelanotide for the treatment of erectile dysfunction (ED). [click link for full article]

INTROL? CF Panel I Control INTROL? CF Panel I Control


INTROL? CF Panel I Control
INTROL? CF Panel I Control is DNA quality control material that is used to monitor the performance of genetic tests used in the detection of variations in the gene called cystic fibrosis transmembrane conductance regulator (CFTR) in human blood specimens. (Approved: 9/18/2006)

Single Lot of 55lb Bags of Ol'Roy Complete Nutrition Dry


Single Lot of 55lb Bags of Ol'Roy Complete Nutrition Dry Dog Food Voluntarily Recalled in Select Stores by Doane Pet Care (June 6)
This voluntary recall has been issued because FDA detected Salmonella in the product.

Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Clarion County Dairy (June 14)
Consumers who have purchased raw milk from Piney Ridge Farm in New Bethlehem any time after May 21 should discard it immediately due to the risk of Listeria monocytogenes contamination.
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