100 Most Recent Submitted Laboratory News

FDA takes steps to protect public health Agency working with animal, drug and medical communities to promote judicious antimicrobial use 2012-04-11 00:00:00, The U.S. Food and Drug Administration announced today that it is taking three steps to protect public health and promote the judicious use of medically important antibiotics in food-producing animals. Antimicrobial resistance occurs when bacteria or other microbes develop the ability to resist the effects of a drug. Once this occurs, a drug may no longer be as effective in treating various illnesses or infections. Because it is well established that all uses of antimicrobial drugs, in both h( read more).....

Department of Justice enters consent decree with California seafood processor Company agrees to multiple actions to correct FDA food safety violations 2012-04-11 00:00:00, A California seafood importer and processor has agreed to a consent decree with the FDA that prevents the company from manufacturing or distributing fish or fish products until it has corrected conditions in its seafood processing facility alleged to be contaminated with Listeria monocytogenes (L. mono) bacteria. According to a complaint for permanent injunction filed by the Department of Justice on behalf of the FDA, Yamaya USA, Inc., of Torrance, Calif., and its president, Daigo Irifune, p( read more).....

FDA announces plans to pilot end-stage kidney disease technology in new program 2012-04-10 00:00:00, Innovation Pathway aims to reduce time and cost of bringing safe and effective, breakthrough technologies to patients Three products for patients with end stage renal disease (ESRD) have been chosen to participate in the FDA's Innovation Pathway, an evolving system designed to help medical devices reach patients in a safe, timely and collaborative manner. The FDA selected three from 32 product applications ranging from an artificial kidney to devices that assist kidney function that were s( read more).....

Akron Rubber Development Laboratory, Inc's Time Domain (TD) Nuclear Magnetic Resonance (NMR) Capabilities Expand to Help Meet Today's Quality Assurance Needs 2012-04-09 00:00:00, Akron, OH - Determining the state of cure of elastomeric materials is becoming more and more important to today's material development companies and parts manufacturers. Quality Assurance Managers, Production Managers and Material Development Engineers are under increasing pressure to determine a material's performance and service life. ARDL has expanded upon its industry leading experience in testing, analysis and material characterization with the inclusion of its updated Time Domain (TD) Nu( read more).....

Akron Rubber Development Laboratory, Inc Adds to Its Accreditation Independent High Pressure / High Temperature Aging, Rapid Gas Decompression (RGD) Testing and Service Life Prediction Capabilities for Materials Used in the Oil and Gas Industry 2012-04-09 00:00:00, Akron, OH - Polymer engineering and material qualification for oil and gas applications is a daily challenge for engineers as they deal with ever higher pressures and temperatures at new depths and in new gases. Akron Rubber Development Laboratory, Inc. recognizes the need to support the Oil & Gas Industry with independent testing and has expanded its reputation as a world leader in material development and testing by investing in technology and equipment to meet today's down-hole application ( read more).....

FDA enters consent decree with cheese producer due to Listeria contamination 2012-04-09 00:00:00, Washington state cheese processor agrees to FDA food safety action A Washington state cheese processor and distributor has agreed to keep its products off the market until they are proven safe for consumption as part of a consent decree of permanent injunction with the U.S. Food and Drug Administration. Del Bueno, of Grandview, Wash., which processes a variety of cheeses and distributes them to specialty grocery stores and restaurants, and owner Jesus Rodriguez, agreed to terms of the cons( read more).....

CLSI Publishes Revised Guideline on Nucleic Acid Amplification Assays for Molecular Hematopathology 2012-04-05 00:00:00, The Clinical and Laboratory Standards Institute (CLSI) recently published Wayne, Pennsylvania, USA-April 2012-Clinical and Laboratory Standards Institute (CLSI) recently published Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline-Second Edition (MM05-A2). This guideline addresses the performance and application of assays for gene rearrangement and translocations by both polymerase chain reaction (PCR) and reverse-transcriptase PCR techniques, and includes inform( read more).....

FDA proposes lower risk classification for certain tuberculosis tests 2012-04-04 00:00:00, Lower classification will support CDC recommendations The Food and Drug Administration issued a proposed rule today that would encourage the development of a type of test used to detect cases of tuberculosis (TB). This rule would lower the current risk classification for nucleic acid-based tests allowing manufacturers to utilize the faster, more streamlined clearance pathway for medical devices. Nucleic acid-based tuberculosis tests can detect the presence of copies of tuberculosis bacteri( read more).....

Avomeen Analytical Services Renews Registration with Contract Laboratory .com 2012-04-03 00:00:00, Contract Laboratory Inc. is pleased to announce that Avomeen Analytical Services has become a member of its Laboratory Outsource Network - ContractLaboratory.com. Avomeen Analytical Services is a full-service chemical testing laboratory specializing in deformulation, pharmaceutical testing, investigative analysis, product development, and chemical litigation support services. Their independent analytical testing laboratory provides contract research, testing, and problem solving expertise for( read more).....

ARDL's Time Domain (TD) Nuclear Magnetic Resonance (NMR) Capabilities Expand to Help Meet Today's Quality Assurance Needs 2012-04-02 00:00:00, For Immediate Release: April 2, 2012 From: 2887 Gilchrist Road Akron, OH 44305 p.330.794.6600 f.330.794.6610 www.ardl.com ARDL's Time Domain (TD) Nuclear Magnetic Resonance (NMR) Capabilities Expand to Help Meet Today's Quality Assurance Needs Akron, OH - Determining the state of cure of elastomeric materials is becoming more and more important to today's material development companies and parts manufacturers. Quality Assurance Managers, Production Managers and Material( read more).....

Ramboll Finland Registers with Contract Laboratory .com 2012-04-02 00:00:00, Contract Laboratory Inc. is pleased to announce that Ramboll Finland has become a member of its Laboratory Outsource Network - ContractLaboratory.com. Ramboll is a truly multi-disciplinary engineering, design and consultancy company working to meet the distinct needs of their customers across seven markets: buildings, transport, environment, energy, oil and gas, telecoms, and management consulting. With a team of over 10,000 dedicated specialists in 23 countries, Ramboll emphasizes local expe( read more).....

New FDA guidance on considerations used in device approval, de novo decisions 2012-04-01 00:00:00, Clinical data, risks, benefits and patient risk tolerance outlined in process The U.S. Food and Drug Administration today published a first-of-a-kind guidance1 for medical device manufacturers, describing how the benefits and risks of certain medical devices are considered during pre-market review. Premarket approval (PMA) is the FDA process of scientific and regulatory review used to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that suppo( read more).....

Obama administration takes action to address tobacco epidemic 2012-03-30 00:00:00, Today the U.S. Food and Drug Administration (FDA) released two separate draft guidance documents to help fight the tobacco epidemic and stop children from using tobacco. The draft guidance documents implement provisions of the Family Smoking Prevention and Tobacco Control Act that will ultimately provide the public with previously unknown information about the chemicals in tobacco products and help prevent misleading marketing about the risks associated with tobacco products. The first docum( read more).....

EMSL Analytical tests for 4-methylimidazole, the chemical produced during caramel manufacturing 2012-03-29 00:00:00, Coca-Cola Co. and PepsiCo Inc. are modifying the way in which their sodas' caramel coloring is made in order to reduce the amount of a chemical known as 4-methylimidazole. The change is the result of a new California law mandating that drinks carry a warning label if they contain a certain level of carcinogens, and 4-methylimidazole is listed as a cancer-causing agent by the state of California. 4-methylimidazole is created during the caramel cooking process and can be found in many food( read more).....

EMSL Analytical's laboratory identifies smoke/fire damage for property insurance claims 2012-03-27 00:00:00, Residents of approximately 900 homes in Jefferson County, CO have been evacuated from the rural, mountainous area southwest of Denver. So far, the fire has ruined 15 to 25 structures, including 5 homes. A body was also discovered, but the authorities have not been able to determine the cause of death. Investigators suspect that the conflagration may have begun as a prescribed burn initiated last week. Experts believe that the unexpectedly strong winds and recent dry weather contributed to the( read more).....

FDA approves additional blood test for viruses linked to leukemia, neurologic diseases 2012-03-27 00:00:00, Avioq HTLV-I/II Microelisa System, a test designed to detect antibodies to viruses in donors of human blood and blood components that are associated with several diseases, including some forms of leukemia and neurologic diseases, was approved today by the Food and Drug Administration. Avioq HTLV-I/II Microelisa System, is the only test now available that can be used to both screen the blood supply for antibodies to Human T-Lymphotropic Virus Type I (HTLV-I) and Human T-Lymphotropic Virus Type( read more).....

EMSL Analytical offers reliable testing services for Listeria, E. coli, and other food pathogens 2012-03-26 00:00:00, Several varieties of cheese made by El Ranchero Del Sur, LLC of South River, NJ have been recalled due to possible Listeria monocytogenes contamination. Fresh cheese, string cheese, and fresh cheese in banana leaves were distributed to retail stores, supermarkets, and restaurants inNew Jersey andPennsylvania between February 23, 2012 and March 14, 2012. Listeriosis, the infection caused by the bacteria, is usually not life-threatening for people with strong immune systems. Healthy individuals( read more).....

FDA proposes lower risk classification for certain tuberculosis tests Lower classification will support CDC recommendations 2012-03-25 00:00:00, The Food and Drug Administration issued a proposed rule today that would encourage the development of a type of test used to detect cases of tuberculosis (TB). This rule would lower the current risk classification for nucleic acid-based tests allowing manufacturers to utilize the faster, more streamlined clearance pathway for medical devices. Nucleic acid-based tuberculosis tests can detect the presence of copies of tuberculosis bacterium genetic materials (RNA or DNA) in a mucus (sputum) sam( read more).....

OSHA and the Society for Chemical Hazard Communication renew Alliance to promote best practices to reduce worker exposures to chemical hazards 2012-03-23 00:00:00, WASHINGTON - Promoting best practices to reduce worker exposure to hazardous chemicals is the goal of a renewed Alliance between the Occupational Safety and Health Administration (OSHA) and the Society for Chemical Hazard Communication (SCHC). The renewed Alliance will continue to address hazard communication and to increase awareness of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). "More than 32 million workers are exposed to 650,000 hazardous chemical pro( read more).....

USDA Warns of Additional Fraudulent Letters and Calls 2012-03-23 00:00:00, WASHINGTON, March 23, 2012--USDA officials have been notified that additional fraudulent letters and at least one fraudulent phone call have been received by individuals in a number of states. The phone call was received by an individual in Indiana, and letters are being sent by FAX to individuals and businesses in a growing number of states. The letters and call purportedly come from a USDA procurement officer and seek personal information. These letters are false and in no case should a re( read more).....

USDA Publishes Final Rule to Restore the Nation's Forests Through Science and Collaboration 2012-03-23 00:00:00, Secretary Vilsack announces publication of the final land management planning rule WASHINGTON, March 23, 2012 - Agriculture Secretary Tom Vilsack today announced the U.S. Department of Agriculture's final Planning Rule for America's 193-million acre National Forest System that includes stronger protections for forests, water, and wildlife while supporting the economic vitality of rural communities. This final rule - which follows USDA's Feb. 3 publication of the Programmatic Environmental I( read more).....

EMSL Analytical offers advanced testing for crystalline silica, including alpha-quartz, cristobalite, tridymite, and amorphous silica 2012-03-23 00:00:00, Air samples taken at the Second Avenue subway construction site in New York City show high levels of silica dust, which can lead to debilitating health conditions and death. A report completed by the Occupational Safety and Health Administration (OSHA) stated that the air inside the tunnel contained more than three times the allowable level of silica dust. Crystalline silica, a basic component of soil, sand, granite, and other minerals, has been classified as a human lung carcinogen. Breathin( read more).....

EMSL Analytical offers the most precise method of testing for bed bugs available 2012-03-23 00:00:00, A corporation that holds several pest control companies recently released a list of U.S. cities ranked according the number of bed bug treatments performed from January to December 2011 (see below). The numbers in the parentheses reflect shifts in the rankings, compared to January to December 2010. The number of bed bug infestations has skyrocketed in recent years. Scientists speculate that the discontinuation of harmful pesticides, such as DDT, has allowed the pests to thrive and that increa( read more).....

EMSL Analytical tests for lead and other heavy metals in consumer products and environmental samples 2012-03-23 00:00:00, New research, conducted by the Michigan-based nonprofit Ecology Center, has discovered high levels of toxic substances in many pieces of children's costume jewelry that are sold in Walmart and other retailers. The products contained unsafe levels of lead, as well as other dangerous metals such as arsenic, chromium and nickel. Researchers at the Ecology Center tested 99 unique children's and adult jewelry pieces from 14 different retailers (such as Target, Claire's, Forever 21, and Walmart) in( read more).....

USDA Trade Mission to Create Opportunities for U.S. Agriculture in China 2012-03-22 00:00:00, Nearly 40 U.S. Companies to Form Business Ties and Joint Ventures WASHINGTON, March 22, 2012-Acting Under Secretary for Farm and Foreign Agricultural Services Michael Scuse will lead nearly 40 American businesses on a U.S. Department of Agriculture trade mission to China March 23-28. U.S. agricultural exports to China have grown more than 80 percent in the past three years. The USDA trade mission aims to help American businesses strike new deals, strengthen business ties, expand their markets,( read more).....

Obama Administration Announces New Funding for Biomass Research and Development Initiative 2012-03-22 00:00:00, Research to advance next generation biofuels and renewable energy technologies COLUMBUS, Ohio - Today, as President Obama went to Ohio State University to discuss the Administration's all-out, all-of-the-above strategy for American energy, the White House announced up to $35 million over three years to support research and development in advanced biofuels, bioenergy and high-value biobased products. The projects funded through the Biomass Research and Development Initiative (BRDI) - a joint( read more).....

US EPA Administrator Lisa P. Jackson Testimony Before the U.S. Senate, Committee on Environment and Public Works 2012-03-22 00:00:00, Thank you for inviting me to testify on the President's Fiscal Year 2013 budget for the Environmental Protection Agency. I'm joined by the agency's Chief Financial Officer, Barbara Bennett. EPA's budget request of $8.344 billion focuses on fulfilling EPA's core mission of protecting public health and the environment, while making the sacrifices and tough decisions that Americans across the country are making every day. EPA's budget request fully reflects the President's commitment to reducin( read more).....

U.S. Government raising awareness of accidental exposures during National Poison Prevention Week 2012-03-22 00:00:00, (Boston, Mass. - March 20, 2012) - EPA is joining forces with its federal partners to raise awareness of the dangers of poisoning, especially to children, during National Poison Prevention Week, March 18-24. In just the past year, America's 57 poison control centers fielded 4 million calls, treating 2.4 million human poison exposures and handling 1.6 million information calls. EPA, the Centers for Disease Control and Prevention, Health Resources and Services Administration, Consumer Products ( read more).....

USDA Announces Recent Animal Welfare Act and Horse Protection Act Enforcement Actions 2012-03-21 00:00:00, WASHINGTON, March 21, 2012--The U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) is continuing to move more swiftly and consistently to take enforcement action in response to animal welfare violations. As part of its effort to make its actions transparent and accessible to the public, APHIS is highlighting enforcement actions taken in response to violations of the Animal Welfare Act (AWA) and Horse Protection Act (HPA). Copies of documents related to these( read more).....

Rules Proposed to Limit New Uses of Potentially Harmful Chemicals / EPA also calls for additional testing on health and environmental impacts of PBDEs 2012-03-20 00:00:00, WASHINGTON - The U.S. Environmental Protection Agency has proposed that companies be required to report to EPA all new uses, including in domestic or imported products, of five groups of potentially harmful chemicals. Over the years, these chemicals have been used in a range of consumer products and industrial applications, including paints, printing inks, pigments and dyes in textiles, flame retardants in flexible foams, and plasticizers. This action is part of EPA's work to ensure chemical saf( read more).....

EMSL Analytical provides pollen counts using advanced testing methods 2012-03-20 00:00:00, Spring has come early this year, and most of the east coast has been experiencing high pollen counts as a result. On Monday, Atlanta broke a 13 year pollen count record, with 8,164 particles of pollen per cubic meter, reports CNN. More than 60 million Americans suffer from allergies, according to the American Academy of Allergy, Asthma & Immunology. For those who are allergic to pollen, this spring will be especially difficult: the mild winter has allowed plants to release pollen much sooner ( read more).....

ACTA LABORATORIES Registers with Contract Laboratory.com 2012-03-19 00:00:00, ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that ACTA LABORATORIES registers with Contract Laboratory.com's premier Laboratory Outsourcing Network. ACTA Laboratories, Inc. is an FDA registered, cGMP compliant, independent laboratory that provides services directed to the pharmaceutical, nutritional supplement / botanical, and medical device industries. For these industries, ACTA offers consulting and Chemical, Microbiological, and In Vitro Toxicology Tes( read more).....

TOX MONITOR / BSR Registers with Contract Laboratory.com 2012-03-17 00:00:00, ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that TOX MONITOR / BSR registers with Contract Laboratory.com's premier Laboratory Outsourcing Network. TOX MONITOR / BSR is a small, privately owned Acute Toxicology Laboratory celebrating our 35th year of service. Located in suburban Chicago Tox Monito/BSR specializes in the assessment of human health effects of chemicals, household products and pesticides. We also evaluate the efficacy of pest control produc( read more).....

New Study Explores Innovation and Opportunities for Diverse Local Food Distributors 2012-03-16 00:00:00, WASHINGTON, March 16, 2012 -Today, Agriculture Deputy Secretary Kathleen Merrigan released a new report on the distribution practices of eight producer networks and their partners distributing locally or regionally-grown food to retail and foodservice customers. The report, entitled Moving Food Along the Value Chain: Innovations in Regional Food Distribution, shows how these networks tap into the growing commercial demand for local and regional food products while creating additional economic op( read more).....

U.S. Transportation Secretary LaHood Proposes to Streamline Environmental Reviews for Transit Projects, Dramatically Cutting Red Tape and Improving Transparency without Short-Changing the Environment 2012-03-16 00:00:00, First Major Revisions to Environmental Review Process Proposed in Over 20 Years Will Put Americans to Work More Quickly, Revitalize Communities WASHINGTON - Responding to President Obama's call for federal agencies to speed infrastructure development through more efficient environmental reviews, U.S. Transportation Secretary Ray LaHood and Federal Transit Administrator Peter Rogoff today announced they are proposing common-sense changes that would significantly cut red tape for certain transi( read more).....

EMSL Analytical provides quality lead testing services for paint chips, wipes, soil, water, and air samples 2012-03-16 00:00:00, Funding for the lead poisoning prevention programs run by the Centers for Disease Control and Prevention (CDC) has been drastically cut, reports the New York Times. For the 2013 fiscal year, only $2 million is allotted for the greatly needed programs, which previously relied on $29 million to carry out their services. The result will be a major disruption or possible permanent cessation of those services, which include lead paint remediation assistance, the prevention and education programs, ( read more).....

EMSL Analytical offers cadmium and other heavy metals testing services in locations nationwide 2012-03-16 00:00:00, New research indicates that women with higher levels of cadmium in their diets are at a greater risk of developing breast cancer than those who consume less of the heavy metal, reports the LA Times. The study, conducted inSweden, followed approximately 56,000 women for over 12 years to record their diets and breast cancer diagnoses. The Environmental Protection Agency (EPA) has classified cadmium as a probable human carcinogen and notes that oral exposure in animals results in harmful ef( read more).....

CLSI Publishes Revised Standard on Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria 2012-03-15 00:00:00, The Clinical and Laboratory Standards Institute (CLSI) recently published Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition (M11-A8). This standard provides reference methods for the determination of minimal inhibitory concentrations of anaerobic bacteria by agar dilution and broth microdilution. Susceptibility testing is indicated for any organism that contributes to an infectious process warranting antimicrobial chemotherapy if its suscep( read more).....

CLSI Announces Webinar: Verification of AST Methods for the Implementation of the Carbapenem and Cephalosporin Breakpoints 2012-03-15 00:00:00, The Clinical and Laboratory Standards Institute (CLSI) announces the webinar "Verification of AST Methods for the Implementation of the Carbapenem and Cephalosporin Breakpoints," which will take place on April 26, 2012, from 1:00-2:00 PM Eastern (US) Time. Each year, CLSI revises its informational supplement on performance standards for antimicrobial susceptibility testing (AST). In January 2012, CLSI published "Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Second Inf( read more).....

CLSI Announces Webinar: Verification of AST Methods for the Implementation of the Carbapenem and Cephalosporin Breakpoints 2012-03-15 00:00:00, The Clinical and Laboratory Standards Institute (CLSI) is presenting the workshop Tools for Tackling EP23: Laboratory Quality Control Based on Risk Management; Approved Guideline. The workshop will take place on Wednesday, May 23, 2012, from 10:00 AM-3:30 PM Eastern (US) Time at The Radnor Hotel, in St. Davids, Pennsylvania, USA. Participants will learn more about the new CLSI document, Laboratory Quality Control Based on Risk Management; Approved Guideline (EP23-A), and the companion product( read more).....

Statement from Agriculture Secretary Tom Vilsack on the U.S. - Korea Trade Agreement 2012-03-15 00:00:00, WASHINGTON, March 15, 2012-Agriculture Secretary Tom Vilsack made the following statement about the U.S-Korea Trade Agreement, also known as KORUS, which enters into force today. "Today is a monumental day for American farmers and ranchers. Under the new U.S.-Korea trade agreement, two-thirds of the tariffs imposed on U.S. food and agricultural products exported to South Korea are being eliminated. Over the next few years, as additional barriers fall and more U.S. businesses market products ( read more).....

Capzer Pharmaceuticals Registers with Contract Laboratory.com 2012-03-15 00:00:00, ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Capzer Pharmaceuticals registers with Contract Laboratory.com's premier Laboratory Outsourcing Network. Capzer Pharmaceuticals prides ourselves in quality services and commitment to excellence here in America, and are in the process of building business partnership with international companies. Taking advantage of cost-effective products in the world market, we are poised to step into the global business a( read more).....

EPA Celebrates 20th Anniversary of Energy Star/ Americans saved nearly $230 billion in two decades 2012-03-15 00:00:00, WASHINGTON - The U.S. Environmental Protection Agency (EPA) is kicking off the celebration of Energy Star's 20th anniversary by recognizing the 2012 Energy Star award winners for their outstanding leadership and commitment to protecting America's environment through superior energy efficiency. Over the past 20 years, with help from Energy Star partners, American families and businesses have saved about $230 billion on utility bills and prevented more than 1.7 billion metric tons of carbon pollut( read more).....

Agenda 1 Analytical Services Registers with Contract Laboratory.com 2012-03-14 00:00:00, ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Agenda 1 Analytical Services registered with Contract Laboratory.com's premier Laboratory Outsourcing Network. Agenda1 Analytical Services Ltd provides high quality data to the pharmaceutical and wider industries involved in sophisticated manufacturing activities, offering a range of flexible services to a broad group of clients. Agenda 1 spun out from the analytical laboratories of Nektar Therapeutics (UK( read more).....

CDC research shows outbreaks linked to imported foods increasing Fish and spices the most common sources 2012-03-14 00:00:00, Foodborne disease outbreaks caused by imported food appeared to rise in 2009 and 2010, and nearly half of the outbreaks implicated foods imported from areas which previously had not been associated with outbreaks, according to research from the Centers for Disease Control and Prevention, presented today at the International Conference on Emerging Infectious Diseases in Atlanta. "It's too early to say if the recent numbers represent a trend, but CDC officials are analyzing information from 20( read more).....

Marin Biologic Laboratory Renews Registration with Contract Laboratory.com 2012-03-12 00:00:00, ContractLaboratory.com - The Laboratory Outsource Network! is proud to announce that Marin Biologic Laboratory registered with Contract Laboratory.com's premier Laboratory Outsourcing Network. This is Marin Biologic Laboratory's fourth year registered with ContractLaboratory.com Marin Biologic Laboratories is a contract research organization (CRO) that provides custom research and development services for pre-clinical and clinical studies.GLP and GMP compliant assay development, validation a( read more).....

Advanced Clinical Diagnostics Laboratory Registers with Contract Laboratory.com 2012-03-10 00:00:00, ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Advanced Clinical Diagnostics Laboratory registered with Contract Laboratory.com's premier Laboratory Outsourcing Network. Advanced Clinical Diagnostics Laboratory has 4000 sq ft of lab space fully equipped with ware housing, animal facilities, clean room, high speed and ultra centrifuges, iso enviormental chambers for various atmospheric conditions of temp and air mixtures, fermentors with high speed fi( read more).....

APHIS Proposes New Bovine Import Regulations in Line with International Animal Health Standards Proposal Aims to Ensure Health of the U.S. Beef Herd, Assist in Negotiations 2012-03-09 00:00:00, WASHINGTON, March 9, 2012--The U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) announced today it is seeking public review and comment on a proposal to complete efforts to modernize the Agency's import regulations for bovine spongiform encephalopathy (BSE). "This proposal is an important step forward in our efforts to bring our import regulations in line with science-based, international animal health standards," said Dr. John Clifford, APHIS Deputy( read more).....

USDA and Interior Announce Wildlife Conservation Efforts to Support Local Economies and Preserve Farm and Ranch Traditions 2012-03-08 00:00:00, Innovative partnership preserves working lands and supports efforts of private landowners to conserve habitat for at-risk species WASHINGTON, March 8, 2012-Agriculture Secretary Tom Vilsack and Secretary of the Interior Ken Salazar today announced a new $33 million partnership with farmers, ranchers and forest landowners to use innovative approaches to restore and protect the habitats for wildlife, including seven at-risk species and other vulnerable game species. The announcement of the( read more).....

BIOSCIENCE LABORATORIES Renews Registration with Contract Laboratory.com 2012-03-08 00:00:00, ContractLaboratory.com - The Laboratory Outsource Network! is proud to announce that BIOSCIENCE LABORATORIES has renewed it's Registration with Contract Laboratory.com's premier Laboratory Outsourcing Network. This has been the fourth year that BIOSCIENCE LABORATORIES has been registered with Contract Laboratory .com For more than 20 years, BioScience Laboratories., Inc. has been the leading resource for antimicrobial product testing and result interpretation grounded in science. Various ind( read more).....

FDA Commissioner Margaret A. Hamburg's Statement on the Surgeon General's Report A Milestone in the Fight to Protect Young Americans from the Dangers of Tobacco Use 2012-03-08 00:00:00, Tobacco use is the leading cause of preventable death in our nation. And until we dramatically decrease the access and appeal of tobacco products to youth, it will remain one of America's most pressing health problems. Today's ground-breaking report by the Surgeon General not only documents the devastating consequences of tobacco use for our nation's youth, but also represents a clarion call for bold action at every level of government to implement proven strategies to keep kids off tobacco. ( read more).....

Life-threatening germ poses threat across medical facilities 2012-03-06 00:00:00, CDC highlights steps to prevent spread of deadly C. difficile bacteria, which impacts patients in nursing homes and outpatient care, not just hospitals For Clinicians: 6 Steps to Prevention 1.Prescribe and use antibiotics carefully. About 50% of all antibiotics given are not needed, unnecessarily raising the risk of C. difficile infections. 2. Test for C. difficile when patients have diarrhea while on antibiotics or within several months of taking them. 3. Isolate patients with C. diffi( read more).....

ATLANTIC PRODUCT SERVICES Renews Registration with Contract Laboratory.com 2012-03-04 00:00:00, ContractLaboratory.com - The Laboratory Outsource Network! is proud to announce that Atlantic Product Services has renewed it's Registration with Contract Laboratory.com's premier Laboratory Outsourcing Network. This has been the second year that Atlantic Product Services has been registered with Contract Laboratory .com Atlantic Product Services Inc. has been providing our customers, a selection of the highest quality of petroleum testing and surveying services for over Twenty-Five Years. W( read more).....

MILLENIUM RESEARCH LABORATORIES Renews Registration with Contract Laboratory.com 2012-03-02 00:00:00, ContractLaboratory.com - The Laboratory Outsource Network! is proud to announce that Millenium Research Laboratories has renewed it's Registation with Contract Laboratory.com's premier Laboratory Outsourcing Network. This has been the fourth year that Millenium Research has been registered with Contract Laboratory .com Millennium Research Laboratories, Inc. was founded with a vision to provide unique and quality solutions to analytical problems in the pharmaceutical and biotech industries. O( read more).....

USDA Announces Final Rule Allowing Importation of Chinese Wooden Handicrafts and Protection of American Agriculture from Harmful Pests 2012-03-01 00:00:00, WASHINGTON, March 1, 2012-The U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) is amending its regulations to allow, under certain conditions, the importation of wooden handicrafts from China. This action allows trade in Chinese wooden handicrafts to resume and continues to protect America's agriculture and natural resources from the introduction of harmful foreign pests. The final rule requires that all wooden handicrafts from China be treated with ( read more).....

La FDA anuncia modificaciones relacionadas con la seguridad en las indicaciones de algunos medicamentos que reducen el colesterol Importantes modificaciones en materia de seguridad con respecto a las indicaciones de algunos medicamentos muy utilizados reductores del colesterol que se conocen como e 2012-02-28 00:00:00, Estos productos, cuando se utilizan junto con dieta y ejercicio, ayudan a las personas a reducir el colesterol "malo" (colesterol contenido en las proteínas de baja densidad). Los productos incluyen: Lipitor (atorvastatina), Lescol (fluvastatina), Mevacor (lovastatina), Altoprev (lovastatina de liberación prolongada), Livalo (pitavastatina), Pravachol (pravastatina), Crestor (rosuvastatina) y Zocor (simvastatina). Los productos combinados incluyen: Advicor (lovastatina/niacina de liberación pro( read more).....

FDA announces safety changes in labeling for some cholesterol-lowering drugs 2012-02-28 00:00:00, Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced today by the U.S. Food and Drug Administration. These products, when used with diet and exercise, help to lower a person's "bad" cholesterol (low-density lipoprotein cholesterol). The products include: Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosu( read more).....

USDA Announces Additional Funding to Control European Grapevine Moth in California 2012-02-24 00:00:00, WASHINGTON, Feb. 24, 2012--Agriculture Secretary Tom Vilsack today announced the availability of $8 million in emergency funding to prevent the spread of European grapevine moth (EGVM) in California. "The European grapevine moth is a significant invasive pest that has the potential to devastate California's $5.7 billion table grape, wine, raisin and other industries, as well as the hundreds-of-thousands of jobs connected to each," said Vilsack. "The program is a great example of cooperative ( read more).....

USDA Extends Comment Period for Corn Genetically Engineered for Herbicide Tolerance 2012-02-22 00:00:00, WASHINGTON, Feb 22, 2012--The U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) today announced a public comment period extension through April 27 on a petition received from Dow AgroScience LLC seeking a determination of nonregulated status for corn designated as DAS-40278-9. On December 27, 2011, APHIS published a notice in the Federal Register advising the public that we received a petition for corn event DAS-40278-9, which has been genetically eng( read more).....

First accreditation granted for certification of supply chain security management systems 2012-02-22 00:00:00, Lloyds Register of Quality Assurance (LRQA) has become the first certification body to be accredited by the United Kingdom Accreditation Service (UKAS) for ISO 28000 certification. ISO 28000 (Specification for security management systems for the supply chain) has been developed by ISO in response to demand from industry for a standard to improve the security of supply chains. Following its acceptance by the European cooperation for Accreditation (EA), ISO 28000 has been added to the list o( read more).....

FDA seeks $4.5 billion to support medical product development, protect patients and ensure safety of the food supply 2012-02-22 00:00:00, FY 2013 request reflects a 17 percent increase from FY 2012 budget The U.S. Food and Drug Administration is requesting a budget of $4.5 billion to protect and promote the public health as part of the President's fiscal year (FY) 2013 budget - a 17 percent increase over the FDA enacted budget for FY 2012. Industry user fees would fund 98 percent of the proposed budget increase. The FY 2013 request covers the period from Oct. 1, 2012 through Sept 30, 2013. In addition to recommending new use( read more).....

Accredited certification is a valuable tool for businesses says international survey 2012-02-22 00:00:00, The value of accredited certification as a valuable business tool has been confirmed by a survey conducted by the International Accreditation Forum (IAF), of which UKAS is a principal member. The global survey received over 4,000 responses from businesses operating across a diverse range of industries in more than 40 different economies. The survey aimed to clarify the drivers for seeking certification, the factors involved in choosing a certification body, and the extent of any benefit deri( read more).....

Amstel Testing Ltd on the boil with first UK accreditation for cookware testing 2012-02-21 00:00:00, \The first UK based accreditation for testing cookware has been granted to Amstel Testing Ltd by the United Kingdom Accreditation Service (UKAS). This accreditation is to ISO/IEC 17025:2005 for the main cookware testing clauses (BS EN 12983-1:2000+A1:2004). Additionally, Amstel is the only UKAS accredited laboratory in the UK covering standards for: non-stick endurance/hob suitability (DD CEN/TS 12983:2005 Part 2); ovenware (BS EN 13834:2007+A1:2009); stove-top kettles (BS EN 13750:2002); and g( read more).....

FDA acts to bolster supply of critically needed cancer drugs 2012-02-21 00:00:00, Announcements build on President Obama's Executive Order The U.S. Food and Drug Administration today announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama's Executive Order to help prevent future drug shortages. "A drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority of his administration," said FDA Commissioner Margaret A. Ham( read more).....

USDA Strengthens Service for America's Agricultural Exporters APHIS Announces Improvements to its Phytosanitary Certificate and Issuance Tracking System 2012-02-16 00:00:00, WASHINGTON, February 16, 2012-America's agricultural exporters play a vital role in building an economy that continues to grow, innovate and out-compete the rest of the world. Farm exports in fiscal year (FY) 2011 showed record growth, reaching a high of $137.4 billion, and supported 1.15 million jobs here on the home front. The U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) supports trade and economic growth by continually striving to improve services for ( read more).....

U.S., China Sign Plan of Strategic Cooperation in Agriculture 2012-02-16 00:00:00, Des Moines, Iowa, Feb. 16, 2012-Agriculture Secretary Tom Vilsack and China's Minister of Agriculture Han Changfu today signed an historic Plan of Strategic Cooperation that will guide the two countries' agricultural relationship for the next 5 years. The plan was signed as part of the U.S.-China Agricultural Symposium held today at the World Food Prize Hall of Laureates. The symposium focused on bilateral cooperation in the areas of food safety, food security and sustainable agriculture, as( read more).....

U.S. Organic Industry Praises U.S.-EU Partnership in Organic Trade 2012-02-15 00:00:00, WASHINGTON, Feb. 15, 2012-Earlier today, Agriculture Deputy Secretary Kathleen Merrigan announced that the United States and the European Union formed a partnership that will recognize the two organic programs as equivalent and allow access to each other's markets. Formal letters creating this partnership were signed earlier today in Nuremberg, Germany, by Merrigan; Dacian Cioloº, European Commissioner for Agriculture and Rural Development; and Ambassador Isi Siddiqui, U.S. Trade Representative ( read more).....

European Union and United States Agree to Historic New Partnership on Organic Trade 2012-02-15 00:00:00, NUREMBERG, Germany, Feb. 15, 2012-The European Union and the United States announced today that beginning June 1, 2012, organic products certified in Europe or in the United States may be sold as organic in either region. This partnership between the two largest organic-producers in the world will establish a strong foundation from which to promote organic agriculture, benefiting the growing organic industry and supporting jobs and businesses on a global scale. The organics sector in the( read more).....

FDA seeks $4.5 billion to support medical product development, protect patients and ensure safety of the food supply 2012-02-13 00:00:00, The U.S. Food and Drug Administration is requesting a budget of $4.5 billion to protect and promote the public health as part of the President's fiscal year (FY) 2013 budget - a 17 percent increase over the FDA enacted budget for FY 2012. Industry user fees would fund 98 percent of the proposed budget increase. The FY 2013 request covers the period from Oct. 1, 2012 through Sept 30, 2013. In addition to recommending new user fees to support the review of generic drugs and biosimilars, the FDA( read more).....

FDA seeks $4.5 billion to support medical product development, protect patients and ensure safety of the food supply 2012-02-13 00:00:00, FY 2013 request reflects a 17 percent increase from FY 2012 budget The U.S. Food and Drug Administration is requesting a budget of $4.5 billion to protect and promote the public health as part of the President's fiscal year (FY) 2013 budget - a 17 percent increase over the FDA enacted budget for FY 2012. Industry user fees would fund 98 percent of the proposed budget increase. The FY 2013 request covers the period from Oct. 1, 2012 through Sept 30, 2013. In addition to recommending new use( read more).....

FDA issues draft guidance on biosimilar product development 2012-02-09 00:00:00, For Immediate Release: Feb. 9, 2012 Media Inquiries: Sandy Walsh, 301-796-4669; sandy.walsh@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. "When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process," ( read more).....

FDA issues draft guidance on biosimilar product development 2012-02-09 00:00:00, The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. "When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research. "These draft documents are designed to help industry develop ( read more).....

USDA and Partners to Provide New Genetic Resources to Support Global Agricultural Development 2012-02-08 00:00:00, WASHINGTON, Feb. 8, 2012 -The U.S. Department of Agriculture's (USDA) Agricultural Research Service (ARS), partnering with Bioversity International and the Global Crop Diversity Trust, has launched the Germplasm Resources Information Network-Global (GRIN-Global), a powerful but easy-to-use, Internet-based information management system for the world's plant genebanks. Genebanks support agricultural productivity and global food security goals by ensuring access to plant genetic resources in the f( read more).....

USDA Announces Latest Actions to Combat Fraud and Enhance SNAP Program Integrity 2012-02-06 00:00:00, Strengthened Measures Help Fight Fraud in Nation's Most Critical Nutrition Assistance Progra WASHINGTON, Feb. 6, 2012 - USDA Under Secretary Kevin Concannon today announced first quarter results for fiscal year 2012 in the effort to identify and eliminate fraudulent retailers from the Supplemental Nutrition Assistance Program (SNAP). From October 1 through December 31, 2011, USDA staff took final actions to:  Sanction, through fines or temporary disqualifications, more than 225 stores found ( read more).....

USDA Announces Funding for Two Renewable Energy Programs 2012-02-03 00:00:00, WASHINGTON, Feb. 3, 2012 - Agriculture Secretary Tom Vilsack today announced the availability of funds for Fiscal Year 2012 for two key programs to encourage the use of renewable biomass and production of advanced biofuels. About $25 million will be made available through each program. "President Obama has laid out a new era for American energy-an economy fueled by homegrown and alternative energy sources that will be designed and produced by American workers," said Vilsack. "These programs( read more).....

FDA and industry reach agreement in principle on medical device user fees 2012-02-01 00:00:00, The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon. Under a user fee program, industry agrees to pay fees to help fund a portion of ( read more).....

FDA completes work on three drug user fee programs 2012-01-31 00:00:00, The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients, FDA Commissioner Margaret A. Hamburg, M.D. said today. The recommendations were transmitted to Congress today by Health and Human Services Secretary Kathleen Sebelius. The programs include the fifth authorization of the Prescription Drug User Fee Act (PDUFA), and new user f( read more).....

Department of Justice files consent decree of permanent injunction against Ranbaxy 2012-01-25 00:00:00, Generic drug manufacturer agrees to remedy deviations from the current good manufacturing practice requirements and to correct data integrity problems at numerous facilities The Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a consent decree of permanent injunction against generic drug manufacturer Ranbaxy in the U.S. District Court of Maryland. The consent decree was filed against Ranbaxy Laboratories, Ltd., an Indian corporation and its subsidiary Ranba( read more).....

A2LA SUPPORTING SGIP's SMART GRID INITIATIVES 2012-01-25 00:00:00, Frederick, Maryland - The American Association for Laboratory Accreditation (A2LA) announces their commitment to supporting the objectives of the recently released "Interoperability Process Reference Manual (IPRM) - Version 2.0". The IPRM is issued by the Smart Grid Interoperability Panel (SGIP), the organization initiated by the National Institute of Standards and Technology (NIST) to coordinate standards deployment for the Smart Grid, and provides recommendations on processes and best practic( read more).....

A2LA SUPPORTING SGIP's SMART GRID INITIATIVES 2012-01-25 00:00:00, Frederick, Maryland - The American Association for Laboratory Accreditation (A2LA) announces their commitment to supporting the objectives of the recently released "Interoperability Process Reference Manual (IPRM) - Version 2.0". The IPRM is issued by the Smart Grid Interoperability Panel (SGIP), the organization initiated by the National Institute of Standards and Technology (NIST) to coordinate standards deployment for the Smart Grid, and provides recommendations on processes and best practic( read more).....

CLSI Announces 2012 Teleconferences on Antimicrobial Susceptibility Testing Standards 2012-01-15 00:00:00, The Clinical and Laboratory Standards Institute (CLSI) and the Association of Public Health Laboratories (APHL) recently announced upcoming January and February educational teleconferences about antimicrobial susceptibility testing (AST) for clinical and public health laboratories. Participants may register for the upcoming teleconferences at www.aphl.org/clsi. These teleconferences are based on the recently published updated editions of the CLSI AST standards, Performance Standards for Antimicr( read more).....

CLSI Publishes Revised Guideline for Physician and Nonphysician Provider-Performed Microscopy Testing 2012-01-15 00:00:00, The Clinical and Laboratory Standards Institute (CLSI) recently published Physician and Nonphysician Provider-Performed Microscopy Testing; Approved Guideline-Second Edition (POCT10-A2). This guideline provides information on specimen collection, test methodologies, procedural steps, reporting of results, and the quality assurance aspects of provider-performed microscopy (PPM). POCT10-A2 replaces its previous version, HS02-A. "In this revision, a large selection of images were added to improv( read more).....

FDA to protect important class of antimicrobial drugs for treating human illness 2012-01-04 00:00:00, The U.S. Food and Drug Administration today issued an order that prohibits certain uses of the cephalosporin class of antimicrobial drugs in cattle, swine, chickens and turkeys effective April 5, 2012. Antimicrobial drugs are important for treating disease in both humans and animals. This new order takes into consideration the substantial public comment FDA received on a similar order that it issued in 2008, but revoked prior to implementation. FDA is taking this action to preserve the e( read more).....

FDA proposes draft guidelines intended to improve the representation of women in medical device clinical studies 2011-12-16 00:00:00, Draft guidance aimed to address the historic underrepresentation of women in clinical studies was issued by the U.S. Food and Drug Administration today. Intended for medical device developers and manufacturers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate. "The FDA recommends that investigators and manufacturers strive to enroll representative proportions of both women( read more).....

Trident catheter valve - Model Number: 380851 2011-12-12 00:00:00, The Therapeutic Goods Administration (TGA) advises that certain lots of the Trident Catheter Valve (Australian Register of Therapeutic Goods (ARTG) number 107139) are being recalled. The Trident Catheter Valve is used for connecting a urinary catheter to an overnight drainage bag. It gives users the opportunity to retrain the bladder and reduce the reliance on urine bags. The recall is being conducted because a routine sterility test on the Trident Catheter Valve in a particular set of lot( read more).....

UKAS Assessment Programme for Accreditation for Certification of Green Deal Advisors and Installers 2011-12-12 00:00:00, The deadline for applications to participate in the UKAS programme for the accreditation of certification bodies to certify Green Deal Advisors and Installers expired on 30 September 2011. UKAS received 33 applications from organisations who wish to participate in the pilot programme and all 33 applicants will have the opportunity to be assessed over the next 10 months. The assessments will be carried out in two stages, with a pilot group of 20 applicants commencing their assessments immediat( read more).....

TGA reforms: a blueprint for TGA's future 2011-12-08 00:00:00, Government to improve regulation of therapeutic goods media release, The Hon Catherine King MP 8 December 2011 The Australian Government has released its response to several major reviews of therapeutic goods regulation that have been undertaken over the past 18 months. These reviews include: the review to improve the transparency of the public consultations on the regulatory framework for advertising therapeutic goods the Auditor-General's report on Therapeutic Goods Regu( read more).....

Respirtek ISO 17025 Business Management Improvements 2011-11-22 00:00:00, After 10 years of diverse bioenvironmental research and testing, RespirTek has obtained ISO 17025 Certification and is continuing to improve upon the strong foundations of excellent customer service and quality testing that has served our clients well over the years. RespirTek remains committed to these foundational objectives that have led us to continually impact the scientific, engineering, and product development communities. We are pleased to announce the following improvements to our orga( read more).....

Respirtek, Inc. ISO 17025 Accreditation Announcement 2011-11-22 00:00:00, After 10 years of diverse bioenvironmental research and testing, RespirTek has obtained ISO 17025 Certification and is continuing to improve upon the strong foundations of excellent customer service and quality testing that has served our clients well over the years. RespirTek remains committed to these foundational objectives that have led us to continually impact the scientific, engineering, and product development communities. We are pleased to announce the following improvements to our orga( read more).....

UKAS Accreditation for Inspection of Fairground and Amusement Park Devices - Pilot Project Update 2011-11-11 00:00:00, The first pilot assessment by UKAS of an inspection body involved in inspection of fairground and amusement park devices is now under way. A pre- assessment of Jacobs Engineering (UK) Ltd, Ashton Lane, Manchester was conducted by UKAS recently, where Jacobs' readiness to proceed to the initial assessment stage was established and an action plan was agreed. At the initial assessment, UKAS will establish the inspection body's compliance with the international standard ISO/IEC 17020, Generic cr( read more).....

FDA issues two draft guidance documents to facilitate investigational medical device studies in humans 2011-11-10 00:00:00, The U.S. Food and Drug Administration today issued a draft guidance aimed at fostering early-stage development of medical devices within the United States. Doing early-stage development is important to help stimulate U.S.-based innovation and contribute to medical research. The guidance document contains new approaches towards early feasibility studies, which are conducted in a small number of patients early in device development, while providing appropriate human subject protections. Such ( read more).....

ACCREDITATION MATTERS ISSUE 8 NOW AVAILABLE 2011-11-08 00:00:00, A new edition of Accreditation Matters, UKAS' newsletter for the public sector, has been released. Issue 8 gives information about the appointment of UKAS as the accreditation body for the Green Deal, the Government's flagship programme for improving the energy efficiency of British properties, new accreditation activity in support of plant health inspections, crime scene investigations and telecommunications services, as well as general background on UKAS and accreditation. Accreditation M( read more).....

Nova now provides Sterility and Endotoxin Testing for the Radiopharmaceutical Industry 2011-11-01 00:00:00, Radiopharmaceutical sterility testing is required during the sterilization validation process as well as for routine product release testing. USP <71> sterility testing is an official test to determine sterility of a product. Nova's understanding of USP <71> is important to the radiopharmaceutical industry because it allows us to assist in designing a sterility test validation process. USP <71> testing of radiopharmaceuticals is a scientifically complex process that must be performed by trained ( read more).....

FDA invests $2 million in partnerships through Centers of Excellence in Regulatory Science and Innovation 2011-10-26 00:00:00, The U.S. Food and Drug Administration today announced the award of $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI). The centers, which will be located at the University of Maryland and Georgetown University, will focus on strengthening science and training needed to modernize and improve the ways drugs and medical devices are reviewed and evaluated, a major focus within the FDA. In August 2011, the agency released the strategic plan for( read more).....

2011-10-26 00:00:00, FDA approves first generic olanzapine to treat schizophrenia, bipolar disorder The U.S. Food and Drug Administration today approved the first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydus (olanzapine orally disintegrating tablets) to treat schizophrenia and bipolar disorder. Schizophrenia is a chronic, severe, and disabling brain disorder. About 1 percent of Americans have this illness. Symptoms people with schizophrenia have include: hearing voices, believing other pe( read more).....

FDA approves Onfi to treat severe type of seizures 2011-10-26 00:00:00, On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older. As Onfi is intended to treat a disease or condition that affects fewer than 200,000 people in the United States, it was granted orphan drug designation by the FDA. "Lennox-Gastaut syndrome is a severe form of epilepsy that causes debilitating seizures," said Russell K( read more).....

Illinois warehouse Prevents unsafe food distribution from rodent-infested facility 2011-10-19 00:00:00, FDA: U.S. Marshals seize food products at U.S. Marshals, acting at the request of the FDA, seized various food products stored in a warehouse owned by Chetak Chicago LLC, in Streamwood, Ill., on October 17, 2011. The products were seized under a warrant issued by the U.S. District Court for the Northern District of Illinois. The FDA initiated the seizure after finding extensive evidence of unsanitary conditions throughout the warehouse during a recent inspection. Investigators collected more ( read more).....

FDA proposes lower risk classification, special controls for external pacemakers Classification of "preamendment" device clarifies FDA review process 2011-10-19 00:00:00, The U.S. Food and Drug Administration has issued a proposed rule and draft special controls guidance lowering the risk classification for external pacemaker pulse generators from Class III (high-risk) to Class II (moderate-risk). External pacemaker pulse generators are used temporarily to regulate a patient's heartbeat until a permanent pacemaker can be implanted. They are also used following heart surgery or after a heart attack to control irregular heartbeats. "The FDA has assessed ( read more).....

FDA approves Ferriprox to treat patients with excess iron in the body 2011-10-19 00:00:00, The U.S. Food and Drug Administration today approved Ferriprox (deferiprone) to treat patients with iron overload due to blood transfusions in patients with thalassemia, a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy. Patients with thalassemia have excess iron in the body from the frequent blood transfusions (transfusional iron overload), a condition that is serious and can be fatal. These patients also have a risk of developing liver di( read more).....

FDA: U.S. Marshals seize foods stored at Washington State facility FDA inspection found rodent and insect infestation 2011-10-11 00:00:00, At the request of the U.S. Food and Drug Administration, U.S. Marshals seized food products held at the food storage and processing facility of Dominguez Foods of Washington, Inc., in Zillah, Wash., on Sept. 30, 2011. The seized products had been subject to a detention order issued by FDA on Sept. 2, 2011, following an FDA inspection of the facility that found evidence of widespread and active rodent and insect infestation in the facility's warehouse and processing area. In a complaint fil( read more).....