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Suntron Corporation Announces FDA Quality Certification at Sugar Land, TX Facility: Suntron Corporation, a leading provider of integrated electronic manufacturing solutions EMS and Commercial Off The Shelf Technology COTS design solutions with six (6) North American Facilities, announced today that the Company's Gulf Coast Operation located in Sugar Land, Texas is registered with the Food and Drug Administration FDA to build...; Tags: FDA, Suntron Corp.; Research articles 2009-02-16
FDA and Kaplan EduNeering Expand Partnership: New agreement creates the foundation for expanded cooperation among US and non-US government regulatory agencies to achieve consistent regulatory enforcement PRINCETON, N.J. -- Kaplan EduNeering, a leading provider of compliance and knowledge management solutions and the US Food and Drug Administration FDA have expanded their Cooperative Research and Development...; Tags: FDA, Kaplan EduNeering, Kaplan Inc.; Research articles 2009-02-11
The right glove for the right job at the right price: keeping gloves on hand: [ILLUSTRATION OMITTED] Hospitals may be breathing a small, albeit possibly temporary, sigh of relief as cost increases for medical gloves seem to have slowed. "After a very volatile year in 2008, the market has already begun to stabilize," commented Poyee Tai, executive vice president, Tronex Industries. "In October...; Tags: Cardinal Health Inc., FDA, Kimberly-Clark Corp., Medline Industries Inc.; Research articles 2009-02-01
Ustekinumab approval delayed by FDA: The Food and Drug Administration has requested more information about ustekinumab before it is approved for treating moderate to severe plaque psoriasis, according to Centocor Inc., the manufacturer of the monoclonal antibody. In a statement issued in December, the company reported that the information requested by the FDA includes...; Tags: Centocor Inc., FDA; Research articles 2009-02-01
New sweeteners hit soft drinks: NEW YORK -- Coca-Cola Co. has introduced Sprite Green, a reduced-calorie soft drink that contains a natural sweetener called Truvia that is based on rebiana, a substance found in the herb trevia. The sweetener was developed jointly by Coca-Cola and Cargill Inc. The initial launch is focusing on locations...; Tags: Cargill Inc., Coca-Cola Co., FDA; Research articles 2009-01-12

UCB Receives Complete Response Letter From U.S. FDA for Use of Cimzia(R) in Rheumatoid Arthritis Patients: Press release - regulated information - UCB announced today that the US Food and Drug Administration FDA has issued a Complete Response Letter CRL relating to the Biologics License Application BLA of Cimzia® certolizumab pegol, the first PEGylated anti-TNF, for the treatment of rheumatoid arthritis RA. As a prerequisite...; Tags: FDA, UCB S.A.; Research articles 2009-01-05
Benzoyl peroxide recall: CSI USA Inc. is recalling all lots of its over-the-counter 10% benzoyl peroxide ache cream because it's contaminated with Burkholderia cepacia bacteria. The company and the FDA said that consumers--especially those who have cuts, scrapes, or rashes, or who have weakened immune systems--should stop using the products because of infection...; Tags: CSI USA Inc., Dollar General Corp., FDA, Wal-Mart Stores Inc.; Research articles 2009-01-01
More generics receive clearance for marketing by the FDA: WASHINGTON -- The Actavis Group has received Food and Drug Administration approval to market bupropion hydrochloride extended-release tablets, 150 mg. The company also markets a 300-mg version of the product, indicated for the treatment of major depressive disorder. Annual sales of brand and generic versions of the drug in...; Tags: FDA, Mylan Pharmaceuticals Inc., Sandoz; Research articles 2008-12-08
Tests of formula lead to confusion, calls for a recall: Disclosure that laboratory tests have detected traces of contamination in several major brands of infant formula generated concern and confusion Wednesday, with a national consumer's group and the Illinois attorney general demanding a Food and Drug Administration recall and the federal agency saying it had released inaccurate information on what...; Tags: FDA, Mead Johnson & Co.; Research articles 2008-11-27
Akorn-Strides, LLC Announces FDA Approval for Pamidronate Disodium Injection, 3 mg/mL and 9 mg/mL: LAKE FOREST, Ill. -- Akorn-Strides, LLC today announced that the U.S. Food and Drug Administration has granted approval for an Abbreviated New Drug Application ANDA for Pamidronate Disodium Injection, 3 mg/mL and 9 mg/mL in 10 mL vials. Akorn-Strides, LLC is a Joint Venture that was formed in 2004 by...; Tags: Akorn Inc., FDA, Strides Arcolab Ltd.; Research articles 2008-11-03
Omnilux at CVS: Photo Therapeutics is offering its Omnilux New-U handheld LED device for skin rejuvenation at CVS Caremark Corp. pharmacies. The device has Food and Drug Administration clearance for over-the-counter sales.; Tags: CVS Caremark Corp., CVS Corp., FDA; Research articles 2008-10-27
Acusphere Announces Signing of a Definitive Agreement with Cephalon: WATERTOWN, Mass. -- Acusphere, Inc. (NASDAQ:ACUS) today announced the signing of a definitive agreement with Cephalon, Inc. to provide $20 million in upfront financing by purchasing a $15 million senior secured convertible note and by paying a $5 million upfront fee for an exclusive worldwide license to AI-525, a preclinical-stage...; Tags: agreement, Cephalon Inc., Company, FDA, FINANCE, Government, Nasdaq Stock Market Inc., Readers; Research articles 2008-10-25
FDA Advisory Committee Provides Clear Path Forward For Development of Amyloid Imaging Agents For Alzheimer's Disease: -Avid Radiopharmaceuticals Applauds FDA and Advisory Committee for Advancing the Field of Molecular Imaging- SILVER SPRING, Md. -- Avid Radiopharmaceuticals today announced that the U.S. Food and Drug Administration FDA Peripheral and CNS Advisory Committee provided strong support for development of amyloid imaging agents to test for the presence...; Tags: Avid Technology Inc., Clear, FDA, FINANCE, Government, imaging, SOFTWARE; Research articles 2008-10-23
New Director Elected to California Healthcare Institute Board: LA JOLLA, Calif. -- The California Healthcare Institute CHI today announced that Michael A. Friedman, M.D., president and chief executive officer of City of Hope, a leading cancer research, treatment and education center, was elected to its board of directors. CHI is a non-profit public policy research organization, representing leading...; Tags: Biotechnology, board, California, CALIFORNIA HEALTHCARE INSTITUTE, diagnostics, FDA, Friedman, Government, HEALTHCARE; Research articles 2008-10-22
HHS Preparing to Open FDA Offices in China, India, Europe, and Latin America This Year: Globalization of the Agency a Key Part of Import Safety Action Plan to Enhance Product Safety WASHINGTON -- The U.S. Department of Health and Human Services will send the first U.S. Food and Drug Administration FDA staff to China, India, Europe, and Latin America before the end of 2008,...; Tags: Administration, China, FDA, food, Globalization, Government, Manufacturing, secretary, Strategy, U.S. Department of Health and Human Services; Research articles 2008-10-16
Cinryze Receives FDA Approval for Prophylaxis Against Hereditary Angioedema Attacks: -- First and Only C1 Inhibitor Therapy to Be Approved to Prevent Potentially Fatal Condition -- NEW YORK -- Lev Pharmaceuticals, Inc. (OTCBB: LEVP.OB) today announced that the U.S. Food and Drug Administration FDA approved Cinryze[TM] (C1 inhibitor [human]) for routine prophylaxis against angioedema attacks in adolescent and adult...; Tags: attack, FDA, patient, SEC, SECURITY, therapy, ViroPharma Inc.; Research articles 2008-10-10
FDA Approves New Injection Site for RISPERDAL® CONSTA® for Schizophrenia Treatment: CAMBRIDGE, Mass. -- Alkermes, Inc. (NASDAQ: ALKS) today announced that patients with schizophrenia now have a new administration option for RISPERDAL([R]) CONSTA([R]) [risperidone Long-Acting Injection]. The U.S. Food and Drug Administration FDA has approved a new injection site, the deltoid muscle in the arm, for RISPERDAL CONSTA for the treatment...; Tags: American Psychiatric Association, FDA, Government, injection, medication, patient, therapy; Research articles 2008-10-09
HepaLife Acquires Liver Support Technology, Tested in America's Largest-Ever Human Clinical Trial for Bioartificial Liver Assist Devices: HepaLife Bolsters Development and Strengthens Its IP Portfolio Through Acquisition of Bioartificial Liver Technology: Clinically Evaluated in over 170 Human Patients, with 12 Additional Patents and Licenses, and FDA's 'Orphan Drug' and 'Fast-Track' Designation BOSTON -- HepaLife Technologies, Inc. (OTCBB: HPLF) (FWB: HL1) (WKN: 500625), developers of the first-of-its-kind...; Tags: acquisition, Company, FDA, FINANCE, Government, Investment, patient, R&D, SEC, U.S. Department of Agriculture; Research articles 2008-10-07
Applied Robotics Announces New Meat Gripper: New Meat Gripper Adheres to All Food Production Cleaning Requirements and is Manufactured With Extremely Light Weight Materials Approved by the FDA and USDA GLENVILLE, N.Y. -- Applied Robotics Inc., a leading global manufacturer of robotic end-of-arm tooling and connectivity solutions, announced today its newest gripper product designed specifically...; Tags: FDA, food, Government, Manufacturing, Meat, robotics, Robots, U.S. Department of Agriculture; Research articles 2008-10-06
Home Diagnostics: Home Diagnostics recently received 510k clearance from the Food and Drug Administration for the world's smallest blood glucose meter, TRUE2go, and for TRUEresult, the company's latest advanced performance, no-coding meter for at-home testing. [ILLUSTRATION OMITTED] "Over the past three years we made capital investments in excess of $15...; Tags: FDA, Home Diagnostics Inc.; Research articles 2008-10-06