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Global Regulatory News Center
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![The U.S. Food and Drug Administration today approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used for multiple indications including prevention of deep vein thrombosis (DVT), a potentially deadly blood clotting condition.
Approved for use in 1993, Lovenox is made from heparin, a blood-thinning drug whose active ingredient is a naturally-derived complex mixture of sugar molecules.
For a generic drug to be approved by the FDA, the manufacturer must demonstrate it contains the same active ingredient as the brand-name drug. The process can b]()
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FDA Approves First Generic Enoxaparin Sodium Injection
The U.S. Food and Drug Administration today approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used for multiple indications including prevention of deep vein thrombosis (DVT), a potentially deadly blood clotting condition.
Approved for use in 1993, Lovenox is made from heparin, a blood-thinning drug whose active ingredient is a naturally-derived complex mixture of sugar molecules.
For a generic drug to be approved by the FDA, the manufactur( read more)..... |
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Currenta Registers with ContractLaboratory.com - The Laboratory Outsource Network!
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Currenta Analytics has joined it's premier Laboratory Outsourcing Network.
CURRENTA offers an extensive range of analytical services for research, development and production in industry. Companies worldwide rely on the skills of our experts and entrust their samples to our laboratories. Our methods range from standardized quality inspections to demanding structural analyses. Basic methods such as elemental( read more)..... |
![For Immediate Release: July 22, 2010
FDA says Keystone kits are unapproved new drugs, and have not been proven safe and effective
At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $39,000 worth of products labeled as cyanide antidote kits from Keystone Pharmaceuticals in Laguna Hills, California. The seizure warrant was issued by the U.S. District Court for the Central District of California.
Marketed for use in cases of cyanide poisoning, Keystone distributes the kits primarily to hospitals in the United States and Canada. The products contain a Sodium]()
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Federal Government Seizes Cyanide Antidote Kits from California Company
For Immediate Release: July 22, 2010
FDA says Keystone kits are unapproved new drugs, and have not been proven safe and effective
At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $39,000 worth of products labeled as cyanide antidote kits from Keystone Pharmaceuticals in Laguna Hills, California. The seizure warrant was issued by the U.S. District Court for the Central District of California.
Marketed for use in cases of cyanide poisoning, Keystone distri( read more)..... |
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Marin Biological Laboratories Registers with ContractLaboratory.com - The Laboratory Outsource Network!
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Marin Biological Laboratories Inc has joined it's premier Laboratory Outsourcing Network.
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 and testing services
Our mission is to provide unparalleled client research services in the fore( read more)..... |
![The U.S. Environmental Protection Agency (EPA), the National Institute of Environmental Health Sciences National Toxicology Program (NTP) and the National Institute of Health Chemical Genomics Center (NCGC) welcome the U.S. Food and Drug Administration (FDA) to the Tox21 collaboration. The Tox21 collaboration merges federal agency resources (research, funding and testing tools) to develop ways to more effectively predict how chemicals will affect human health and the environment. The collaboration was established in 2008 to develop models that will be able to better predict how chemicals will]()
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FDA and Other Federal Agencies Collaborate to Improve Chemical Screening
The U.S. Environmental Protection Agency (EPA), the National Institute of Environmental Health Sciences National Toxicology Program (NTP) and the National Institute of Health Chemical Genomics Center (NCGC) welcome the U.S. Food and Drug Administration (FDA) to the Tox21 collaboration. The Tox21 collaboration merges federal agency resources (research, funding and testing tools) to develop ways to more effectively predict how chemicals will affect human health and the environment. The collaborati( read more)..... |
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RJR Consulting Registers with GlobalRegulatory.com
GLobalRegulatory.com - The Regulatory Network! is pleased to announce that RJR Consulting Inc. has joined it's premier Network.
RJR Consulting, Inc. is a global regulatory consulting firm serving companies, governments and organizations within the Life Science industry. Specializing in regulatory compliance within the Pharmaceutical and Medical Device industries, we provide a wide range of consulting services to companies of all sizes.
Our focus is delivering exceptional client service an( read more)..... |
![The FDA is warning the public that certain Advair Diskus inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used.
Advair Diskus (fluticasone propionate and salmeterol inhalation powder) is an inhalerused to treat patients with asthma and chronic obstructive pulmonary disease.
The products were reported stolen in August 2009 from a GlaxoSmithKline warehouse near Richmond, Va. The inhalers found recently were the first from the stolen lots to be found in comme]()
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FDA Warns Consumers, Pharmacists, and Wholesalers Not to Use Stolen Advair Diskus Inhalers
The FDA is warning the public that certain Advair Diskus inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used.
Advair Diskus (fluticasone propionate and salmeterol inhalation powder) is an inhalerused to treat patients with asthma and chronic obstructive pulmonary disease.
The products were reported stolen in August 2009 from a GlaxoSmithKline warehouse nea( read more)..... |
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Alliance Contract Pharma Registers with ContractLaboratory.com - The Laboratory Outsource Network!
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Alliance Contract Pharma has joined it's premier Laboratory Outsourcing Network.
Alliance Contract Pharma is a leader in providing value-added services to our customers by creating a successful partnership with them throughout their project. Our pledge is to establish lasting relationships with our customers by exceeding their expectations and gaining their trust through exceptional performance.
Contract( read more)..... |
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Helix Biological Laboratories Registers with ContractLaboratory.com - The Laboratory Outsource Network!
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Helix Biological Laboratories has joined it's premier Laboratory Outsourcing Network.
Helix Biological Laboratory LLC is a full service bioanalytical laboratory that is engaged in a wide variety of biological testing, analytical and consulting services. It is the goal at Helix Biological Laboratory to provide clients with a comprehensive range of services to meet their specialized needs.
Helix Biologica( read more)..... |
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InSymbiosis Registers with ContractLaboratory.com - The Laboratory Outsource Network!
InSymbiosis is a contract research organization (CRO) providing customized drug development services to the global biopharmaceutical and biotechnology industries. At InSymbiosis, we utilize our expertise to plan, design, execute and deliver preclinical and Phase I clinical research and development projects on behalf of our clients. Our combination of a CRO and a consulting model provides clients the option to engage InSymbiosis as a CRO, as a consulting and project management group or a combinat( read more)..... |
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Intertek launches carbon off-set programme for clients
Intertek, the leading international provider of quality and safety services, today launched a programme to offer its clients carbon-offsets for its auditing services in China. It is the start of a staged global roll-out by the company to enable its clients to measure and offset the carbon dioxide (CO2) generated through their use of Intertek's global services.
Multinational companies are increasingly trying to quantify their total CO2 footprint across their complex global supply chains and cr( read more)..... |
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Global Pharma Devices Joins Contract Laboratory
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Global Pharma Device Solutions has joined it's premier Laboratory Outsourcing Network.
Global PharmaDevice Solutions (GDPS) is a Limited Liability Company that offer GXP compliance consulting and analytical testing services to the pharmaceutical and medical device industries around the globe. In our consulting division, GPDS is built with seasoned consultants and affiliates, including former FDA investigato( read more)..... |
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Activation Laboratories Registers with ContractLaboratory.com - The Laboratory Outsource Network!
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that Activation Labs has joined it's premier Laboratory Outsourcing Network.
The Actlabs Group of Companies provides contract analytical services covering all aspects of analysis from academic research applications to routine quality control functions.
We provide our services to many fields, including Geochemical, Petroleum, Industrial Minerals, Forensic, Pharmaceutical & Clinical, Environmental & Occupation( read more)..... |
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NTS Registers with ContractLaboratory.com - The Laboratory Outsource Network!
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that NTS has joined it's premier Laboratory Outsourcing Network.
NTS (NASDAQ: NTSC) provides companies and government organizations throughout the world with process and product compliance services, technical resources, design engineering services and program management support. Our significant intellectual and physical assets ensure we can manage and support the changing needs of our customers, just as we have ( read more)..... |
![Top Seven Tips on How To Improve 2010 -- New Years Resolutions To Help Change Your Employment Opportunities
Greg McKinnon, Founder and President of McKinnon Targeted Recruiters Provides Recommendations for Finding New Employment Opportunities
Toronto, Ontario - December 28, 2009 -- Not in recent history has a new year been more universally anticipated. As 2009 winds down, the books will soon close on a year that brought economic hardship for millions -including enormous financial losses and crippling unemployment numbers. As the global economy corrects and readjusts in this next year, w]()
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Press Release
Top Seven Tips on How To Improve 2010 -- New Years Resolutions To Help Change Your Employment Opportunities
Greg McKinnon, Founder and President of McKinnon Targeted Recruiters Provides Recommendations for Finding New Employment Opportunities
Toronto, Ontario - December 28, 2009 -- Not in recent history has a new year been more universally anticipated. As 2009 winds down, the books will soon close on a year that brought economic hardship for millions -including enormous financial losses a( read more)..... |
![WASHINGTON, D.C. (Friday, December 25, 2009) - Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement on today's vote by the Senate to pass]()
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Press Release
WASHINGTON, D.C. (Friday, December 25, 2009) - Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement on today's vote by the Senate to pass "The Patient Protection and Affordable Care Act of 2009":
"The health care reform bill passed today by the Senate includes many provisions which serve as early Christmas presents for patients living with debilitating diseases such as cancer, Multiple Sclerosis, HIV/AIDS and a host of rare diseases. Thes( read more)..... |
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Press Release
Itasca, IL - October 7, 2009: Sterigenics International, a global leader in sterilization services for the
medical device and pharmaceutical industries, announced today the signing of a multi-year exclusive
agreement with John B. Kowalski, Ph.D., to serve as a Senior Staff Consultant with the SteriPro
Consulting team.
John is a broadly trained microbiologist and has 30 years experience in the development, validation,
and transfer of sterilization processes for medical products, mainly with ( read more)..... |
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Press Release
LEUVEN, BELGIUM, October 29, 2009: The Board of Directors of Sterigenics International, the world's
leading provider of contract sterilisation services for the medical device industry, has approved further
expansion of the Petit Rechain, Belgium facility.
This expansion is to deal with the increased customer demand noticed in the last 18 months and is
seen as the next step in the company's long term strategy to create a network of equivalent sterilizers.
It provides incremental capacity as ( read more)..... |
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BASi Launches Two Solutions to Automated Blood Collection
(October 27, 2009; WEST LAFAYETTE, IN) â?" BASi is proud to announce two new products for
automated blood collection (ABC) â?" Culex® ABC and Culex®-L ABC, which provide solutions to
automated blood sampling. BASi is the industry leader in specialized instrumentation and
accessories for in vivo sampling products.
The BASi family of Culex products has always provided researchers the best automated
means to collect in vivo samples. The new Culex ABC units are simplified versions of the orig( read more)..... |
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Press Release
Contract Laboratory.com - The Laboratory Outsource Network is pleased to announce that A. Daigger & Company has registered to become part of their premier laboratory outsourcing network.
For more than 115 years, A. Daigger & Company has served the research science market in the U.S. They ship to more than 80 countries and have been actively exporting lab equipment and supplies for the last 25 years. The Daigger Catalog is found in thousands of laboratories across the globe.
Daigger stocks( read more)..... |
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Press Release
Contract Laboratory.com - The Laboratory Outsource Network is pleased to announce that Helix Biological Laboratory has registered to become part of its premier laboratory outsourcing network.
Helix Biological Laboratory LLC is a bioanalytical-testing laboratory specializing in the detection and identification of microbial organisms that are found in a variety of water sources. The microbial organisms that their laboratory tests for include: fecal indicator bacteria, species of pathogenic wat( read more)..... |
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Press Release
Contract Laboratory.com - The Laboratory Outsource Network is pleased to announce that BioChem has registered to become part of its premier laboratory outsourcing network.
Founded in 1973 by Dr. Walter Massmann (+ 11 August 1998), a medical specialist in pharmacology and microbiology Limited Company (GmbH) since 1981.
BioChem is an independent scientific and technical contract laboratory in Karlsruhe. It was founded in the 70's by Dr Walter Massmann, a medical specialist in pharmacology a( read more)..... |
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Press Release
Contract Laboratory.com - The Laboratory Outsource Network is pleased to announce that Intertek Semko AB has registered to become part of their premier laboratory outsourcing network.
Testing Everywhere for Markets Anywhere. In today's global marketplace, the products you manufacture, distribute or retail are subject to numerous product safety standards and industry requirements. Choose Intertek as your product testing and certification partner and their international network of testing exper( read more)..... |
![Contract Laboratory.com - The Laboratory Outsource Network is pleased to announce that Triad Forensics Laboratory has registered to become part of their premier laboratory outsourcing network.
Affordable Excellence in Analytical Testing and Forensic Case Work. At Triad Forensics Laboratory they customize testing to meet your needs. They will work with you to develop the best testing methods for your particular application or specification(s). Their testing services range from chemical analysis to environmental testing to physical characterization. They can examine almost anything that you c]()
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Press Release
Contract Laboratory.com - The Laboratory Outsource Network is pleased to announce that Triad Forensics Laboratory has registered to become part of their premier laboratory outsourcing network.
Affordable Excellence in Analytical Testing and Forensic Case Work. At Triad Forensics Laboratory they customize testing to meet your needs. They will work with you to develop the best testing methods for your particular application or specification(s). Their testing services range from chemical analysi( read more)..... |
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Press Release
Research Triangle Park, NC and Tampa, FL (21 September 2009) - Magellan BioScience Group, Inc.
(Magellan), a pioneer in innovative drug development from marine sources, and Zen-Bio, Inc. (Zen-Bio)
announced today that they will begin a multidisciplinary drug discovery collaboration to identify novel marine
microbial compounds that have potential as tools for biological research and ultimately the discovery of new
medicines.
This collaboration will bring together Magellan's unique collection( read more)..... |
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Press Release
AUK Technical Services LTD (ATS LTD www.auk.com) is pleased to announce that our client DigiCom Electronics, 5327 Jacuzzi Street, Unit 3N Richmond, CA 94804 (email mo@digicom.org) has received ISO 13485:2003 and ISO 9001:2008 certification for its electronics manufacturing operation. DigiCom is a full service contract manufacturer, offering design prototyping, and full pc board manufacturing in house. ATS LTD provided all the Quality System documentation and advisement throughout the entire ( read more)..... |
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Press Release
DAVIE, FL--(Marketwire - June 22, 2009) - Crystal3 Laboratories, Inc., an affiliate of Analytical Maintenance Services, Inc. (AMS) known throughout the pharmaceutical and nutraceutical industries for high quality analytical equipment qualification and maintenance, announces the expansion of new analytical services offered through its FDA and DEA registered cGMP analytical chemistry laboratory in Davie, Florida.
According to Duran S. Schmidt, M.S., President of C3Labs, "Nealie C. Newberger, P( read more)..... |
![DAVIE, FL--(Marketwire - June 22, 2009) - Crystal3 Laboratories, Inc., an affiliate of Analytical Maintenance Services, Inc. (AMS) known throughout the pharmaceutical and nutraceutical industries for high quality analytical equipment qualification and maintenance, announces the expansion of new analytical services offered through its FDA and DEA registered cGMP analytical chemistry laboratory in Davie, Florida. According to Duran S. Schmidt, M.S., President of C3Labs,]()
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Press Release
DAVIE, FL--(Marketwire - June 22, 2009) - Crystal3 Laboratories, Inc., an affiliate of Analytical Maintenance Services, Inc. (AMS) known throughout the pharmaceutical and nutraceutical industries for high quality analytical equipment qualification and maintenance, announces the expansion of new analytical services offered through its FDA and DEA registered cGMP analytical chemistry laboratory in Davie, Florida. According to Duran S. Schmidt, M.S., President of C3Labs, "Nealie C. Newberger, Ph.D.( read more)..... |
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LDTD Technology Now Available at BASi
(August 6, 2009; WEST LAFAYETTE, IN) â?" BASi provides clients with increased sample
analysis speed and quick turnaround with the LDTD technology. Fast screening is combined
with accurate quantification results, to benefit any bioanalytical studies.
LDTD (Laser Diode Thermal Desorption) technology is an innovative technique that
introduces all samples into the mass spectrometer by a rapid laser thermal desorption process,
where they are ionized by an atmospheric pressure chemical reaction (( read more)..... |
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Press Release
Oak Park, IL, May 18, 2009 - PreLabs, LLC, a Chicago-based contract research organization, is pleased to announce the addition of Stuart Knight as the Global Director of Business Development. In the newly created position, Stuart will lead the company's business development opportunities by expanding and developing strategic client relationships. His industry experience positions him to understand client requirements and effectively collaborate with the global pharmaceutical, biotechnology and m( read more)..... |
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Press Release
Oak Park, IL, October 1, 2008 - Biologic Safety Research Inc. (BSR) announced today it is joining PreLabs, LLC to expand its operations. The existing BSR management team will integrate into the PreLabs organization and continue to actively guide the future of the expanded contract laboratory. Additionally, PreLabs has appointed Boris Predovich to serve as President/CEO and Philippe Baneux DVM as Chief Scientific Officer for the newly expanded company.
Biologic Safety Research has been providi( read more)..... |
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Press Release
GeneuityT Clinical Research Services is exhibiting at the 18th Annual Partnerships with CROs Conference in Orlando, Florida April 28-30, 2009.
This meeting will explore the best methods of forming, managing and sustaining clinical research outsourcing partnerships. We invite you to visit Booth No. 640 to learn more about services available through Geneuity. While you're visiting us there, be sure to register to win an iPod Shuffle.
For more information about this conference and Geneuity's( read more)..... |
![FDA has approved two new tests, developed by Bedford, Mass.-based Hologic, to screen for high-risk human papillomavirus types, the Boston Herald reports. Currently, there is only one FDA-approved test for HPV on the market, the Herald reports. Certain strains of HPV are a precursor to cervical cancer (McConville, Boston Herald, 3/14). According to U.S. News & World Report's]()
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Press Release
FDA has approved two new tests, developed by Bedford, Mass.-based Hologic, to screen for high-risk human papillomavirus types, the Boston Herald reports. Currently, there is only one FDA-approved test for HPV on the market, the Herald reports. Certain strains of HPV are a precursor to cervical cancer (McConville, Boston Herald, 3/14). According to U.S. News & World Report's "On Women," about 80% of women become infected with the sexually transmitted virus at some point in their lives, but in mos( read more)..... |
![Margaret Hamburg, whom President Obama has nominated as FDA commissioner, would face]()
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Press Release
Margaret Hamburg, whom President Obama has nominated as FDA commissioner, would face "several crises at the beginning of her term," as congressional lawmakers have the agency under investigation on "multiple fronts," the Wall Street Journal reports. In recent years, FDA has faced problems related to imported medications, nationwide salmonella outbreaks and complaints from agency scientists about the process used to make regulatory decisions.
According to the Journal, Hamburg "encountered a si( read more)..... |
![LONDON, March 17 (Reuters) - Britain's Financial Services Authority (FSA) will on Wednesday publish a blueprint for a shake-up of global banking regulation aimed at preventing a recurrence of the financial crisis weighing on the world economy.
The report, commissioned by British Prime Minister Gordon Brown at the height of the banking crisis last October, is likely to shape discussions at next month's summit meeting between leaders of the G20 countries.
Analysts say its key recommendations could include an increase in banks' minimum capital requirements as well as closer regulation of h]()
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Press Release
LONDON, March 17 (Reuters) - Britain's Financial Services Authority (FSA) will on Wednesday publish a blueprint for a shake-up of global banking regulation aimed at preventing a recurrence of the financial crisis weighing on the world economy.
The report, commissioned by British Prime Minister Gordon Brown at the height of the banking crisis last October, is likely to shape discussions at next month's summit meeting between leaders of the G20 countries.
Analysts say its key recommendation( read more)..... |
![HERZLIYA PITUACH, Israel - (BUSINESS WIRE) - CorAssist Cardiovascular Ltd., a developer of novel therapeutic devices for Diastolic Heart Failure (DHF), announced today that it has raised $5.25 million in a private financing led by Aurum Ventures MKI. The round was joined by previous investors Ofer Hi-Tech Group, Yozma Management, Evergreen Venture Partners and Argonaut Ventures.]()
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Press Release
HERZLIYA PITUACH, Israel - (BUSINESS WIRE) - CorAssist Cardiovascular Ltd., a developer of novel therapeutic devices for Diastolic Heart Failure (DHF), announced today that it has raised $5.25 million in a private financing led by Aurum Ventures MKI. The round was joined by previous investors Ofer Hi-Tech Group, Yozma Management, Evergreen Venture Partners and Argonaut Ventures.
"We have made significant progress with the ImCardiaT, as well as with our minimally invasive devices, the ImCard( read more)..... |
![WAUWATOSA, Wis.--(BUSINESS WIRE)--March 13, 2009--Medical testing meets medical]()
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Press Release
WAUWATOSA, Wis.--(BUSINESS WIRE)--March 13, 2009--Medical testing meets medical "texting" with the US Food and Drug Administration clearance of GE Healthcare's latest ECG (electrocardiogram) solution, the portable MAC 800, based on cell phone technology. Targeting physician's offices and the pharmaceutical industry, GE's entry into the portable ECG market is as practical as it is innovative.
Originally developed and introduced in China, for China in 2008, the lightweight portable device combi( read more)..... |
![NATICK, Mass., March 12 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that Moody's Investors Service has raised the Company's rating outlook to stable from negative. In addition, Moody's upgraded the Company's U.S. public bond rating to Ba1 from Ba2 and its liquidity rating to SGL-2 from SGL-3, while affirming its corporate credit rating at Ba1.
Moody's said the revised rating outlook reflects: (1) improved covenant cushions provided by recent amendments to the Company's bank facility; (2) generally steady market share for key drug-eluting stent (DES) a]()
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Press Release
NATICK, Mass., March 12 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that Moody's Investors Service has raised the Company's rating outlook to stable from negative. In addition, Moody's upgraded the Company's U.S. public bond rating to Ba1 from Ba2 and its liquidity rating to SGL-2 from SGL-3, while affirming its corporate credit rating at Ba1.
Moody's said the revised rating outlook reflects: (1) improved covenant cushions provided by recent amendments ( read more)..... |
![The U.S. Food and Drug Administration today unveiled a new collaboration initiative with the Houston-based Alliance for NanoHealth (ANH) and its eight member institutions to help speed development of safe and effective medical products in the emerging field of nanotechnology.
Under a Memorandum of Understanding, the FDA/ANH Nanotechnology Initiative will work to expand knowledge of how nanoparticles behave and affect biologic systems, and to facilitate the development of tests and processes that might mitigate the risks associated with nanoengineered products. All outcomes from this public-]()
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Press Release
The U.S. Food and Drug Administration today unveiled a new collaboration initiative with the Houston-based Alliance for NanoHealth (ANH) and its eight member institutions to help speed development of safe and effective medical products in the emerging field of nanotechnology.
Under a Memorandum of Understanding, the FDA/ANH Nanotechnology Initiative will work to expand knowledge of how nanoparticles behave and affect biologic systems, and to facilitate the development of tests and processes t( read more)..... |
![Certain adhesive patches that deliver medication through the skin have been found to be a risk to patient safety. The patches, if worn while undergoing magnetic resonance imaging scans or MRIs, can cause skin burns, says the U.S. Food and Drug Administration today.
The patches of concern include both brand name and generic products and patches purchased over the counter without a prescription.
The FDA issued the Public Health Advisory on transdermal drug patches after learning that a warning was missing on some patches that contain aluminum or other metals in their non-adhesive backing.]()
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Press Release
Certain adhesive patches that deliver medication through the skin have been found to be a risk to patient safety. The patches, if worn while undergoing magnetic resonance imaging scans or MRIs, can cause skin burns, says the U.S. Food and Drug Administration today.
The patches of concern include both brand name and generic products and patches purchased over the counter without a prescription.
The FDA issued the Public Health Advisory on transdermal drug patches after learning that a warni( read more)..... |
![The U.S. Food and Drug Administration today announced its approval of a device that reduces the severity of adhesions in children undergoing open-heart surgery.
Repel-CV is a synthetic film barrier inserted over the heart just before a surgeon closes the chest following an open-heart procedure. During the early healing stages, the temporary, absorbable barrier helps reduce the severity of post-surgical adhesions.
Adhesions are bands of scar tissue that develop after surgery, infection, or other trauma. The bands can develop in any part of the body but are most commonly found in the abdom]()
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Press Release
The U.S. Food and Drug Administration today announced its approval of a device that reduces the severity of adhesions in children undergoing open-heart surgery.
Repel-CV is a synthetic film barrier inserted over the heart just before a surgeon closes the chest following an open-heart procedure. During the early healing stages, the temporary, absorbable barrier helps reduce the severity of post-surgical adhesions.
Adhesions are bands of scar tissue that develop after surgery, infection, or ( read more)..... |
![Agency warns against chronic use of these products to treat gastrointestinal disorders
The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.
Manufacturers will be required to implement a risk evaluation and mitigation strategy, or R]()
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Press Release
Agency warns against chronic use of these products to treat gastrointestinal disorders
The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer t( read more)..... |
![ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that EMSL has registered to become of the their premier Laboratory Outsourcing Network.
As the nation's leading environmental testing firm, EMSL's network of nationwide laboratories has been providing quality analytical services since 1981. We offer a wide array of analytical testing services to support environmental investigations focused on asbestos, microbiology, lead paint, environmental chemistry, indoor air quality, industrial hygiene and food testing. Additionally, we also provide materials testing, ch]()
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Press Release
ContractLaboratory.com - The Laboratory Outsource Network! is pleased to announce that EMSL has registered to become of the their premier Laboratory Outsourcing Network.
As the nation's leading environmental testing firm, EMSL's network of nationwide laboratories has been providing quality analytical services since 1981. We offer a wide array of analytical testing services to support environmental investigations focused on asbestos, microbiology, lead paint, environmental chemistry, indoor a( read more)..... |
![The U.S. Food and Drug Administration announced today that California device manufacturer Cardinal Health 303 Inc., formerly known as Alaris Medical Systems Inc., and three of its top executives have signed an amended consent decree to correct violations of current Good Manufacturing Practice (cGMP) requirements in the company's infusion pumps.
Infusion pumps are devices intended for controlled delivery of intravenous solutions and medications to patients.
Under the terms of the amended consent decree, Cardinal 303 agrees to comply with the cGMP requirements and Quality System (QS) regul]()
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Press Release
The U.S. Food and Drug Administration announced today that California device manufacturer Cardinal Health 303 Inc., formerly known as Alaris Medical Systems Inc., and three of its top executives have signed an amended consent decree to correct violations of current Good Manufacturing Practice (cGMP) requirements in the company's infusion pumps.
Infusion pumps are devices intended for controlled delivery of intravenous solutions and medications to patients.
Under the terms of the amended co( read more)..... |
![The U.S. Food and Drug Administration today approved a humanitarian device exemption for the first implantable device that delivers intermittent electrical therapy deep within the brain to suppress the symptoms associated with severe obsessive-compulsive disorder (OCD).
The U.S. Food and Drug Administration today approved a humanitarian device exemption for the first implantable device that delivers intermittent electrical therapy deep within the brain to suppress the symptoms associated with severe obsessive-compulsive disorder (OCD).
The Reclaim system uses a small electrical generator]()
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Press Release
The U.S. Food and Drug Administration today approved a humanitarian device exemption for the first implantable device that delivers intermittent electrical therapy deep within the brain to suppress the symptoms associated with severe obsessive-compulsive disorder (OCD).
The U.S. Food and Drug Administration today approved a humanitarian device exemption for the first implantable device that delivers intermittent electrical therapy deep within the brain to suppress the symptoms associated with( read more)..... |
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Press Release
Mettler-Toledo Hi-Speed announces the introduction of its value priced checkweigher for mild to moderate washdown applications; the A300. Designed specifically for smaller packaging lines where space is at a premium, it can accommodate a variety of packages in a compact 30" of line space. The A300 is economically priced and delivers a rate of up to 165 ppm (packages per minute).
The stainless steel construction of the A300 features an open design that allows easy cleaning and sanitizing in ( read more)..... |
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Press Release
RAPS Honors Walker, Michor, Hoffman and Matsumoto
For Outstanding Contributions to Healthcare Product Regulatory Profession.
Global Leadership Award
Introduced last year, the Global Leadership Award recognizes professionals who exemplify leadership
and contributions toward worldwide development of the regulatory profession and RAPS.
This year's recipient, Salma Michor, PhD, RAC, is an independent consultant to the pharmaceutical
and medical device sectors, specializing in regulatory affa( read more)..... |
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Press Release
RT Corp, a global supplier of certified reference materials has introduced its PRS products into the pharmaceutical market. The PRS product line are secondary pharmaceutical reference standards to take the place of in-house standards. They offer convenience and an economical alternative to producing the standards in house. The PRS products are certified to USP, EP and BP primary references. To enhance the value of the PRS products, RTC continually certifies current PRS lots to the newest pri( read more)..... |
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Press Release
Mentor, Ohio - September 15, 2008 - STERIS Isomedix Services is pleased to offer the Gamma Engineering Run program at our Libertyville North, Illinois facility. This unique program allows Customers to study the effects of the gamma process on product components or packaging, and is ideal for evaluating materials compatibility prior to beginning a full scale new product development project.
Engineering runs expose product to a standard gamma irradiation cycle with a typical dose range used for( read more)..... |
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Press Release
09/04/2008 - Nova receives NARSA approval. Nova is now a NARSA registered laboratory and can access the central repository of isolates for investigative studies. NARSA is responsible for tracking and procuring staphylococcal isolates (including S. aureus and the coagulase-negative staphylococci) with reduced susceptibility to vancomycin (MIC's > 4 mg/ml) for inclusion into a central repository (NARSA Repository). NARSA approval will allow Nova to help our clients provide products and services( read more)..... |
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