The U.S. Food and Drug Administration today approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding. The condition, which usually develops in adults, is known as chronic immune thrombocytopenic purpura (ITP), a disease that results in a low number of platelets, the blood components that help with clotting. In patients with chronic ITP, the immune system is believed to destroy platelets and the patient's bone marrow is often unable to compensate for this loss.

St. Jude Medical announced U.S. Food and Drug Administration (FDA) approval of the company's new facility in Arecibo, Puerto Rico, for the manufacturing of pacemakers and cardiac leads. The 150,000 square-foot facility, located in Arecibo's Santana Industrial Park, will initially be used to produce St Jude Medical pacemakers and cardiac leads for domestic and international markets, and the company plans to begin manufacturing implantable cardioverter defibrillators (ICDs) at the facility late this year. The new plant will expand the company's cardiac rhythm management manufacturing capacity and is expected to create at least 1,250 new jobs within the next three years. The approval followed a six-month review that included an on-site evaluation by FDA inspectors. Our success in Puerto Rico reflects our commitment to the highest quality standards, so we are pleased to expand our manufacturing capabilities there, said Daniel J. Starks, chairman, president and chief executive officer of St

The U.S. Food and Drug Administration has approved Xenazine (tetrabenazine) for the treatment of chorea in people with Huntingtons disease. Chorea is the jerky, involuntary movement that occurs in people with this disease. Xenazine is a new drug and is the first treatment of any kind approved in the United States for any symptom of Huntingtons disease. Currently there are no other drugs that are FDA-approved to treat chorea.

Individuals and firms seeking best practices for bringing new medical technologies to market will benefit from a one-day seminar offered by the Beaumont Commercialization Center and Beaumont Hospitals. The event will take place October 7 at Oakland University and is designed for companies and individuals interested in medical device development and strategies for diversifying into the health care industry. The seminar offers the unique perspectives of regulators, hospital buyers, and industry leaders, all synthesized into one constructive day of learning. Experts from the Beaumont Commercialization Center will be joined by representatives from leading medical technology organizations, including U.S. Food & Drug Administration (FDA), Stryker, and Abbott. Planned topics include FDA pre-market approval process, the health care provider buyers' dynamics, and industry case studies of successful commercialization.

The U.S. Food and Drug Administration (FDA) today announced that it has approved this year's seasonal influenza vaccines that include new strains of the virus likely to cause flu in the United States during the 2008-2009 season. The six vaccines and their manufacturers are: CSL Limited, Afluria; GlaxoSmithKline Biologicals, Fluarix; ID Biomedical Corporation of Quebec, FluLaval; MedImmune Vaccines Inc., FluMist; Novartis Vaccines and Diagnostics Limited, Fluvirin; and Sanofi Pasteur Inc., Fluzone.

Centocor announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline for the Biologic License Application for ustekinumab, a subcutaneous biologic therapy, by three months to December 2008. The application, filed by Centocor late in 2007, seeks approval to market ustekinumab for the treatment of adult patients with chronic moderate to severe plaque psoriasis. The FDA extended the review period to provide additional time for review of amendments to the application provided by Centocor within the last three months. The FDA has requested no additional clinical trials.

The Sorin Group announced the U.S. Food and Drug Administration's (FDA) approval to market the REPLY family of dual and single chamber pacemakers.The REPLY pacemaker, the world's smallest dual chamber pacemaker at 8cc's, is Sorin Group's next pacing evolution designed to reduce ventricular pacing and promote natural cardiac function. REPLY integrates Sorin Group's new proprietary SafeR pacing mode. The SafeR technology builds on the Sorin Group's proven AAISafeR pacing mode first introduced in Europe in September 2003 and in the US in May 2005. AAISafeR switches from AAI to DDD in case of AV block detection, and has been shown to reduce unnecessary pacing in both Sinus Node Disease and unselected AV Block patients1. Delivering unnecessary pacing to the right ventricle has been shown to significantly enhance the risk of patients developing heart failure and atrial fibrillation2.

QRxPharma Limited, a clinical-stage specialty pharmaceutical company focused on the development and commercialization of therapies for pain and central nervous system (CNS) disorders, announced today that the U.S. Food and Drug Administration (FDA) accepted its proposed Phase 3 protocol designs and statistical analyses to demonstrate the efficacy and safety of Q8003IR, an immediate release dual-opioid (morphine plus oxycodone) product intended for the management of moderate to severe acute pain. Pending incorporation of the FDA's recommended modifications, only two Phase 3 trials will be required for NDA filing. Under this streamlined clinical development program, no additional pharmacology, toxicology or long-term clinical safety studies will be required for regulatory submission and market approval.

Bovie Medical Corporation, a manufacturer and marketer of electrosurgical products, announced that the Food & Drug Administration has cleared its Modular Ergonomic Instruments (MEG Laparoscopic line), allowing the MEG line to be marketed and sold throughout the United States. The patent-pending modular forceps and accessories are designed to provide surgeons added comfort while reducing per-procedure costs through the reduction of inventory and obsolescence. The proprietary instruments offer a simpler assembly process for laparoscopic procedures. The MEG line is directed towards the laparoscopic market with estimated worldwide sales exceeding $425 million.

Biomoda, a development stage medical diagnostics company, submitted to the FDA a pre-IDE (Investigational Device Exemption) protocol for a clinical study using Biomoda's proprietary assay for detection of early lung cancer in veterans. The New Mexico state legislature allocated more than $1.6 million over two years towards the study that will screen more than 2000 veterans. This is an essential step in study development, said John Cousins, President of Biomoda. Approval by the FDA of the study design this year allows us to move forward quickly to prove the efficacy of the assay. Approval by the Agency of the results of this study that we expect early next year will provide us the ability to market our assay commercially.

The U.S. Food and Drug Administration has cleared for marketing a test that can help health care professionals determine what type of cancer cells are present in a malignant tumor. The Pathwork Tissue of Origin test compares the genetic material of a patients tumor with genetic information on malignant tumor types stored in a database. It uses a microarray technology to analyze thousands of pieces of genetic material at one time. The test considers 15 common malignant tumor types, including bladder, breast, and colorectal tumors.

The U.S. Food and Drug Administration today warned consumers to avoid eating tomalley in American Lobster (Maine Lobster), regardless of where the lobster was harvested, because of potential contamination with dangerous levels of the toxins that cause Paralytic Shellfish Poisoning (PSP). American lobster, also known as Maine lobster, are harvested from the waters of the Atlantic Ocean from Northeastern Canada to South Carolina, inclusive. The FDA advisory applies only to tomalley, the soft, green substance found in the body cavity of the lobster that functions as the liver and pancreas. Cooking does not eliminate the PSP toxins. However, studies have shown that, even when high levels of PSP toxins are present in lobster tomalley, lobster meat itself is typically unaffected.

IRIS International, after extensive consultation with the US Food and Drug Administration (FDA), intends to resubmit its 510(k) for its NADiA PSA (Prostate Specific Antigen) ultra-sensitive diagnostic test with a prognostic claim. Following FDA advice, IRIS has already submitted a request for a Pre-Investigational Device Exemption meeting (Pre-IDE Meeting), an optional process through which the applicant consults with the FDA for the purpose of improving the quality of submissions and to shorten review times. IRIS will submit a new 510(k) seeking clearance of a prognostic claim for identifying post-prostatectomy patients with low-risk of prostate cancer recurrence, with an estimated timeline for anticipated market introduction in the first half of 2009, it was announced today by Csar Garca, Chairman, President and CEO of IRIS International.

NexMed announced the receipt of a non approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for its topical treatment for erectile dysfunction (ED). The major regulatory issues raised by the FDA were related to the results of the transgenic mouse carcinogenicity study which NexMed completed in 2002. Commenting on today's announcement, Vivian Liu, President and Chief Executive Officer of NexMed said, The transgenic mouse concern raised by the FDA is product specific, and does not affect the dermatological products in our pipeline. While we are disappointed by the FDA's decision, the deficiencies cited in their letter were not unexpected. One positive outcome is the fact that the FDA did not cite the lack of completion of our long term open label safety study as a deficiency. We are encouraged that we do not need to redo this study, which would have taken up to 18 months to complete and at a substantial cost.

The U.S. Food and Drug Administration (FDA) announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. The FDA Commissioners Fellowship Program will provide participants with advanced training in the scientific analysis involved in the safety and regulatory decisions unique to the agencys mission. Attracting the best scientists to FDA helps us make timely decisions and give doctors and patients helpful and accurate advice about treatment options. And timely decisions encourage more investment in developing new drugs and better medical devices, said Deputy Secretary of Health and Human Services Tevi D. Troy. The FDA Commissioners Fellowship Program will not only bring great fellows in the door, but encourage them to make FDA their career.

The U.S. Food and Drug Administration today issued a final regulation that makes early phase 1 clinical drug development safe and efficient by enabling a phased approach to complying with current good manufacturing practice (CGMP) statutes and FDA investigational requirements. To facilitate this new approach, the regulation exempts most phase 1 investigational drugs from the requirements in 21 CFR part 211 FDA will continue to exercise oversight of the manufacture of these drugs under FDAs general statutory CGMP authority and through review of investigational new drug (IND) applications. A companion guidance recommends an approach for complying with CGMP statutory requirements such as standards for the manufacturing facility and equipment, the control of components, as well as testing, stability, packaging, labeling, distribution, and recordkeeping.

Cell Therapeutics has announced that the Company has scheduled a meeting with the U.S. Food and Drug Administration (FDA) in September to discuss the possibility of filing a supplemental Biologics License Application (sBLA) for use of Zevalin-ibritumomab tiuxetan) as consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin's lymphoma. The basis for the filing would be data from the First-line Indolent Trial that CTI recently gained access to through an agreement with Bayer Schering Pharma.

Osmetech has announced that it has received 510(k) clearance from the US Food & Drug Administration ('FDA') for its eSensor Warfarin Sensitivity Test to be used as an aid in the identification of patients at risk for increased sensitivity to the widely used blood-thinning drug, warfarin. The Company also announces that the FDA clearance includes its second generation eSensor XT-8 molecular diagnostics platform. James White, Chief Executive, Osmetech plc, said: The FDA clearance is an important milestone for Osmetech. As we gear up the launch of our warfarin sensitivity test in the US this clearance provides further validation of our strategy of targeting the exciting opportunities in the rapidly developing molecular diagnostics market.

NeuroHealing Pharmaceuticals, a company developing products for individuals with chronic brain injuries, announced that the Food and Drug Administration (FDA) has awarded the company a three-year grant of $1,044,000 to assist in the clinical development of NH001. NH001 is under clinical development to improve the functional outcome of patients in a vegetative state or minimally conscious state following a severe traumatic brain injury. The product has demonstrated promising results in an open label Phase IIa trial and has received authorization from the FDA to begin a double blind Phase II clinical trial, under an open IND. NH001 received Orphan Drug Status from the FDA in 2006.

St. Jude Medical announced U.S. Food and Drug Administration (FDA) approval of the Merlin@home transmitter, an RF wireless technology that remotely monitors patients implanted cardiac devices. The transmitter supports the St. Jude Medical Current RF and Promote RF family of devices and works in conjunction with the St. Jude Medical data management system, Merlin.net Patient Care Network (PCN), to provide complete remote care service for patients and their physicians. Until recently, patients with implanted cardiac devices were typically required to visit doctors offices several times per year to have their device performance checked. With the advent of transmitters capable of downloading and transmitting device data over telephone lines, patients are now able to initiate and perform many of these follow-ups in their own homes.

Energex Systems, announced that it has been granted approval from the Federal Food and Drug Administration (FDA) to utilize its experimental HemoModulation therapy in a clinical trial of HIV infected patients. The purpose of the study will be to demonstrate safety and monitor viral load changes in patients who are not yet eligible for antiviral drug therapy. HIV is a retrovirus that attacks the immune system, destroying or impairing its function. As the disease progresses, the immune system becomes weaker, and the person becomes more susceptible to opportunistic infections. The advanced stage of HIV infection is Acquired Immunodeficiency Syndrome (AIDS). Globally it is estimated that there are 33.2 million people living with HIV/AIDS. Currently the only approved treatments for HIV are drug based therapies that attempt to reduce viral burden (amount of virus in the blood stream) and the virus's ability to replicate. The cost and known side effects from these drug therapies are significa

Genta has announced that the Food and Drug Administration (FDA) has accepted the Company's amendment to its New Drug Application (NDA) for Genasense(R) (oblimersen sodium) Injection as a complete response. The NDA proposed the use of Genasense plus chemotherapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The recent submission was based on new information from the Company's completed, randomized Phase 3 trial that showed, among other findings, a significant increase in overall survival for patients who achieved a complete or partial response when treated with Genasense plus chemotherapy compared with patients treated with chemotherapy alone.

The U.S. Food and Drug Administration today announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research (CDER) will no longer issue approvable or not approvable letters when a drug application is not approved. Instead, CDER will issue a complete response letter at the end of the review period to let a drug company know of the agency's decision on the application. These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form, said Janet Woodcock, M.D., director of the agency's Center for Drug Evaluation and Research (CDER). Thorough and timely review of drug applications is a priority of the FDA, and these new processes will make our communications with sponsors of applications more consistent

Absenteeism and poor job performance resulting from hangovers cost the nation $148 billion annually, according to the Annals of Internal Medicine. Statistics show that 34% of Americans who consume alcohol are binge drinkers and over half (52%) of college students are binge drinkers. DINOCO International Corporation has recently been granted FDA OTC approval to begin marketing and selling its patent pending JACK'S brand of hangover relief medicines to retailers and consumers throughout the U.S. JACK'S Hangover Relief is the first product of its kind to be granted FDA OTC approval for the temporary relief of hangover symptoms.

AccuRev announced a new AJAX-based Web Interface and a native integration with Microsoft Windows Explorer for its process-centric software change and configuration management (SCCM) solution. These new capabilities make it easy to integrate every knowledge worker into the development process and offer new ways to share information. The AccuRev Web Interface, developed with the Google Web Toolkit, provides a desktop look and feel for accessing files, streams, and version differences -- Development managers can easily browse projects, and perform code reviews from any location. Team leads, release engineers or developers may create new streams of development or download files and documents to work on while out of the office.

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced that the U.S. Food and Drug Administration (FDA) has licensed Pentacel, Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine. Pentacel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b (Hib). Pentacel vaccine is approved for use in infants and children 6 weeks through 4 years of age (prior to fifth birthday). Pentacel vaccine is the first and only four-dose diphtheria, tetanus, and acellular pertussis (DTaP)-based combination vaccine for use in infants and young children in the U.S. that includes both poliovirus and Hib antigens.

The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of conventional antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. In 2005, the FDA announced similar labeling changes for atypical antipsychotic drugs. At that time, Boxed Warnings, the FDA's strongest, were added. The Boxed Warning will now be added to an older class of drugs known as conventional antipsychotics. The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis.

The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. Spinal cord injuries can cause paralysis, which can impact the muscles of the chest and abdomen, including the diaphragmthe lower abdominal muscle essential for breathing. Normally, a person inhales when the diaphragm contracts and the lungs expand with aira person exhales when the diaphragm relaxes and the air flows back out of the lungs.

U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the Peoples Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety. The parties are meeting this week in Annapolis, Md., as part of the fourth session under the United States-China Strategic Economic Dialogue (SED).

At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. U.S. Marshals seized all FDA-regulated animal food susceptible to rodent and pest contamination. The seized products violate the Federal Food, Drug, and Cosmetic Act because it was alleged in a case filed by the United States Attorney that they were being held under unsanitary conditions. (The Act uses the term insanitary to describe such conditions).

HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA. Todays action supports the fundamental change in strategy currently underway at FDA to adapt to the demands of the rapidly growing and changing global economy. These funds will expedite implementation of the strategy outlined in the Action Plan for Import Safety and the complementary Food Protection Plan, both released in November 2007. Last year we outlined important changes in how this nation deals with imports. We are moving from an intervention strategy -- where we stand at the border and try to catch things that are unsafe -- to an integrated strategy of prevention with verification. We are rolling the borders back and seeking to build safety and qu

Court Square Group, a professional services firm specializing in strategic information technology, business process and project management consulting, announced that it has launched a Clinical and Regulatory Practice within its Life Sciences Business Unit. Our comprehensive suite of life sciences services addresses the needs of biotech and pharmaceutical firms throughout the drug development lifecycle, said Court Square CEO Keith Parent. The Clinical and Regulatory Practice enables our clients to employ on-demand electronic data capture during clinical trials and couple that data with electronic submissions of required regulatory reporting. Today, we provide both capabilities as on-demand or software-as-a-service (SaaS) applications, allowing clients to quickly employ advanced technology without incurring heavy capital expenditures.

All speakers will be presenting on current approaches to toxicity prediction, including Dr Edwin Matthews of the US FDA who will be giving an overview of toxicity prediction methodologies from a pharmaceutical regulatory perspective. Also relevant to the area of medicine, Dr Romauldo Benigni of the Italian National Institite of Health will present strengths and limitations of models and databases for the prediction of genetic and carcinogenic toxicity. Focusing on the areas of industrial chemical toxicity and environmental risk assessment, Dr Akihiko Hirose of the NIHS will be speaking on emerging areas and technologies covering toxicity biomarkers in predictive systems. In addition Dr Ann Richard will be explaining how the US EPA is currently broadening the foundations for improved toxico-chemoinformatics through the application of computational chemistry in the area of environmental toxicology. Dr Andrew Worth of the ECB will also present on in-silico toxicity prediction tools & Guid

The U.S. Food and Drug Administration today proposed major revisions to the physician labeling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breast-feeding. The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications. Although physician labeling is directed to health care professionals, it is sometimes adapted for use in consumer-directed labeling such as patient package inserts or medication guides when such labeling is approved for a prescription drug.

The U.S. Food and Drug Administration issued a public health advisory to alert patients, caregivers and health care professionals to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the United States after Dec. 31, 2008. CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface. Three HFA-propelled albuterol inhalers have been approved by the FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. In addition, an HFA-propelled inhaler containing levalbuterol, a medicine similar to albuterol, is available as Xopenex HFA Inhalation Aerosol.

The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella. The specific type and source of tomatoes are under investigation. However, preliminary data suggest that raw red plum, red Roma, or round red tomatoes are the cause. At this time, consumers in New Mexico and Texas should limit their tomato consumption to tomatoes that have not been implicated in the outbreak. These include cherry tomatoes, grape tomatoes, tomatoes sold with the vine still attached, and tomatoes grown at home.

As a result of a routine inspection of the Evangers Dog & Cat Food Company manufacturing facilities by the U.S. Food and Drug Administration, the FDA recently raised questions regarding recordkeeping and other issues at the pet food producers facilities. Contrary to a news release issued by the FDA Thursday, April 24, 2008, Evangers continues to make and distribute its products with FDA approval. Evangers is working closely with the FDA and already has addressed many of the FDAs questions. Evangers expects to have the few remaining FDA queries fully satisfied shortly.

Worksoft, provider of solutions that accelerate deployments of SAP applications, announced that its flagship solution Worksoft Certify, can bridge the chasm between the processes of Governance, Risk and Compliance (GRC) and the processes of Application Life Cycle Management. Companies today are not only striving to improve their business processes, they must do so while grappling with compliance issues, said Bruce Johnson, president and CEO of Worksoft. Companies adhering to IT governance implications of Sarbanes-Oxley (SOX), or the required compliance of their respective industries, such as HIPAA and FDA, are looking for a way to shift governance from being a burden to helping them gain and sustain competitive advantages in a highly dynamic global economy. Worksoft can help manage the business process change events between the office of the CIO and the CEO/CFO by enabling timely collaboration and visibility.

The U.S. Food and Drug Administration today issued a final regulation barring certain cattle materials from all animal feed, including pet food. The final rule further protects animals and consumers against bovine spongiform encephalopathy (BSE, also known as mad cow disease). This FDA action serves to further protect the U.S. cattle population from the already low risk of BSE, said Dr. Bernadette Dunham, Director of FDA's Center for Veterinary Medicine. The new rule strengthens existing safeguards. The new measure builds on FDA's 1997 feed regulation, which prohibited the use of certain mammalian proteins in ruminant feed.

The U.S. Food and Drug Administration today delivered recommendations to Congress for two programs that provide funding for the review of pioneer and generic animal drugs. If adopted by Congress, the Animal Drug User Fee Act (ADUFA) reauthorization would provide funding for the review of new animal drug applications for the next five years. In addition, the first generic user fee program (the Animal Generic Drug User Fee Act or AGDUFA) would support the review of generic animal drug applications and maintain current standards of safety and effectiveness. The funding is tied to meeting specific performance goals that will ensure efficient scientific evaluation of the safety and effectiveness of animal drugs.

The U.S. Food and Drug Administration issued an order requiring that Evanger's Dog & Cat Food Co., Inc., in Wheeling, Ill., obtain an emergency permit from the FDA before its canned pet food products enter interstate commerce. A recent inspection revealed significant deviations from prescribed documentation of processes, equipment, and recordkeeping in the production of the company's thermally processed low acid canned food (LACF) products. These problems could result in under-processed pet foods, which can allow the survival and growth of Clostridium botulinum (C. botulinum), a bacterium that causes botulism in some animals as well as in humans.

The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain. Opioids are often prescribed on a continuous basis for patients with late-stage, advanced illness to help alleviate pain. This includes patients with a diagnosis of incurable cancer, end-stage Chronic Obstructive Pulmonary Disease (COPD) from emphysema, heart failure, Alzheimers disease with dementia, HIV/AIDS or other advanced illnesses. Opioids can interfere with normal bowel elimination function by relaxing the intestinal smooth muscles and preventing them from contracting and pushing out waste products. Relistor acts by blocking opioid entrance into the cells thus allowing the bowels to continue to function normally.

SYSPRO, a provider of visionary ERP for the manufacturing pragmatist, has announced the availability of Document Management for SYSPRO, a cost-effective, green-minded solution set that enables mid-market manufacturers to gain new cost and time efficiencies while addressing regulatory compliance mandates. The new software continues SYSPRO's foray into innovations which provide environmentally friendly options for businesses; in this case aimed at growth-oriented visionary businesses who want to reduce paper, as well as gain new efficiencies. Document Management for SYSPRO, which is optionally available with enhanced workflow features, enables organizations to access, manage and automate the routing of all digital content, including scanned paper documents, e-mails, faxes, print streams, application files, e-forms, Web content and multimedia files. The solution is holistically embedded into SYSPRO's standard ERP solution set, enabling workers to access and manage these documents directly

The U.S. Food and Drug Administration approved a heart assist device with a novel design that is the first to mechanically support the weakened heart of a small-sized adult man or woman with heart failure who is at risk of dying while awaiting a heart transplant. Heart assist devices are surgically implanted mechanical pumps that help the heart's ventricle do its work of pumping blood to the rest of the body. Previous models were too large to be placed in the upper abdomen of some women and small-sized men. But the Thoratec HeartMate II Left Ventricular Assist System employs a first-of-a-kind design. Instead of the standard pulsatile pump that simulates the action of the heart, the device uses a continuous flow pump that constantly moves blood with a single moving part, a spinning rotor. This allows the device to be slimmed down to a mere three inches in length and a weight of approximately one pound.

A new drug has been approved to help sufferers of Crohn's disease, the U.S. Food and Drug Administration announced today. Cimzia (certolizumab pegol) received approval for adults with moderate to severe Crohn's disease who have not responded to conventional therapies. This product was approved with a Medication Guide. Crohn's disease is a chronic, inflammatory bowel disease that affects more than 1 million men and women worldwide. It has no cure and its cause is unknown. Crohn's can cause diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. It also can lead to abnormal connections (fistulas) leading from the intestine to the skin or internal organs.

The U.S. Food and Drug Administration has cleared for marketing the first device made from a new form of natural rubber latex, guayule latex. The product, the Yulex Patient Examination Glove, is derived from the guayule bush, a desert plant native to the Southwestern United States. Traditional latex gloves are made from the milky sap of a rubber tree, Hevea braziliensis. The sap contains a protein that may trigger allergic reactions, especially after prolonged and repeated contact. Sensitized people may experience mild reactions such as skin redness, rash, hives, or itching. More severe reactions may include respiratory symptoms such as difficulty breathing, coughing spells and wheezing. Rarely, shock may occur. Estimates vary, but anywhere from 3 percent to 22 percent of all health care workers are sensitized to traditional latex. Available data on the new guayule latex show that even people who are highly allergic to traditional latex do not react on first exposure to guayule latex p

The U.S. Food and Drug Administration today issued a final regulation barring certain cattle materials from all animal feed, including pet food. The final rule further protects animals and consumers against bovine spongiform encephalopathy (BSE, also known as mad cow disease). This FDA action serves to further protect the U.S. cattle population from the already low risk of BSE, said Dr. Bernadette Dunham, Director of FDAs Center for Veterinary Medicine. The new rule strengthens existing safeguards. The materials that can no longer be used in animal feed are the tissues that have the highest risk for carrying the agent thought to cause BSE. These high risk cattle materials are the brains and spinal cords from cattle 30 months of age and older. The entire carcass of cattle not inspected and passed for human consumption is also prohibited, unless the cattle are less than 30 months of age, or the brains and spinal cords have been removed. The risk of BSE in cattle less than 30 months

With safety issues making headlines, pharmaceutical and medical device manufacturers face a rugged regulatory landscape. Organizations are relying on their quality function to navigate regulatory difficulties that could affect production. Proper staffing of quality roles is just one way organizations optimize their quality function and a study by pharmaceutical benchmarking leader Best Practices, LLC found best-in-class companies have a ratio of quality personnel to total manufacturing employees between 1:4 and 1:7. As captured in the benchmarking report, The Quality Function: Structure, Staffing and Execution, Best Practices, LLC, reveals strategic best practices in quality harnessed from survey responses and in-depth interviews with seven top pharmaceutical and medical device company leaders.

CryoLife, a biomaterials, medical device and tissue processing company, announced that it has signed an exclusive three-year agreement with Minneapolis-based Medafor, Inc. Under terms of the agreement CryoLife will distribute Medafor's microporous polysaccharide hemostatic agent for use in cardiac and vascular surgery in the U.S. and for cardiac, vascular and general surgery, other than orthopaedic and ear, nose and throat surgery, outside the U.S. (excluding Japan and China). CryoLife expects to begin distributing Hemostase MPH in the U.S. in the second quarter of 2008, except to approximately 41 hospitals for which Medafor will retain distribution rights until no later than December 31, 2008. Outside of the U.S., CryoLife expects to begin distributing Hemostase MPH in Canada, United Kingdom and Germany in the second quarter of 2008, with distribution in other markets beginning in 2009. Department of Defense hospitals are excluded from CryoLife's territory under the distribution agree

At the request of the U.S. Food and Drug Administration, today U.S. Marshals seized more than 14,000 dosage units of Shangai Regular, Shangai Ultra, Super Shangai, Natural Super Plus, and Lady Shangai. Although labeled as natural supplements, the seized products were all marketed to treat erectile dysfunction (ED), impotency, and/or to provide sexual enhancement, which caused them to be drugs under the Federal Food, Drug, and Cosmetic Act. The seized products, valued at more than $100,000, contain undeclared active ingredients found in FDA-approved prescription drugs for ED, or similar substances. Use of these products may result in serious side effects and may interact in dangerous ways with medications that a consumer may already be taking.