http://www.compliancehome.com/ ComplianceHome is one of the Web's largest library of resources for compliance management of HIPAA, SOX, FISMA, GLBA, FDA, COOP & COG, FFIEC, Basel II, OSHA and ISO 27002/17799. Visit our directories which are the best source on White papers, related news articles, resources on the web, training, webinars, conferences, rules & regulation overview, ask the expert, job and search on vendors, solutions & products. http://www.compliancehome.com/images/rsslogo.gif http://www.compliancehome.com/ en-us Mon, 04 Aug 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13249.html 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. http://www.compliancehome.com/news/FDA/13249.html Mon, 04 Aug 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13246.html 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. http://www.compliancehome.com/news/FDA/13246.html Tue, 29 Jul 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13211.html 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. http://www.compliancehome.com/news/FDA/13211.html Mon, 28 Jul 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13204.html 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. http://www.compliancehome.com/news/FDA/13204.html Wed, 23 Jul 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13174.html 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. http://www.compliancehome.com/news/FDA/13174.html Wed, 23 Jul 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13173.html 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. http://www.compliancehome.com/news/FDA/13173.html Wed, 23 Jul 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13172.html 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. http://www.compliancehome.com/news/FDA/13172.html Tue, 22 Jul 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13169.html 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. http://www.compliancehome.com/news/FDA/13169.html Mon, 21 Jul 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13166.html 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. http://www.compliancehome.com/news/FDA/13166.html Wed, 16 Jul 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13151.html 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. http://www.compliancehome.com/news/FDA/13151.html Wed, 16 Jul 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13148.html 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. http://www.compliancehome.com/news/FDA/13148.html Tue, 15 Jul 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13131.html 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 http://www.compliancehome.com/news/FDA/13131.html Tue, 15 Jul 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13130.html 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. http://www.compliancehome.com/news/FDA/13130.html Fri, 11 Jul 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13121.html 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 http://www.compliancehome.com/news/FDA/13121.html Sun, 29 Jun 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13044.html 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. http://www.compliancehome.com/news/FDA/13044.html Wed, 25 Jun 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13036.html 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. http://www.compliancehome.com/news/FDA/13036.html Mon, 23 Jun 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13020.html 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. http://www.compliancehome.com/news/FDA/13020.html Fri, 20 Jun 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13006.html 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. http://www.compliancehome.com/news/FDA/13006.html Fri, 20 Jun 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13005.html 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. http://www.compliancehome.com/news/FDA/13005.html Fri, 20 Jun 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13004.html 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). http://www.compliancehome.com/news/FDA/13004.html Fri, 20 Jun 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/13003.html 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). http://www.compliancehome.com/news/FDA/13003.html Wed, 11 Jun 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12946.html 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 http://www.compliancehome.com/news/FDA/12946.html Tue, 10 Jun 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12931.html 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. http://www.compliancehome.com/news/FDA/12931.html Mon, 09 Jun 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12917.html 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 http://www.compliancehome.com/news/FDA/12917.html Thu, 05 Jun 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12907.html 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. http://www.compliancehome.com/news/FDA/12907.html Thu, 05 Jun 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12906.html 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. http://www.compliancehome.com/news/FDA/12906.html Thu, 05 Jun 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12905.html 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. http://www.compliancehome.com/news/FDA/12905.html Sun, 04 May 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12718.html 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. http://www.compliancehome.com/news/FDA/12718.html Wed, 30 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12701.html 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. http://www.compliancehome.com/news/FDA/12701.html Tue, 29 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12699.html 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. http://www.compliancehome.com/news/FDA/12699.html Tue, 29 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12698.html 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. http://www.compliancehome.com/news/FDA/12698.html Tue, 29 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12697.html 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. http://www.compliancehome.com/news/FDA/12697.html Tue, 29 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12696.html 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. http://www.compliancehome.com/news/FDA/12696.html Thu, 24 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12677.html 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 http://www.compliancehome.com/news/FDA/12677.html Thu, 24 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12674.html 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. http://www.compliancehome.com/news/FDA/12674.html Thu, 24 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12673.html 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. http://www.compliancehome.com/news/FDA/12673.html Thu, 24 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12672.html 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 http://www.compliancehome.com/news/FDA/12672.html Thu, 24 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12671.html 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 http://www.compliancehome.com/news/FDA/12671.html Sun, 20 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12648.html 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. http://www.compliancehome.com/news/FDA/12648.html Thu, 17 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12641.html 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 http://www.compliancehome.com/news/FDA/12641.html Thu, 10 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12588.html 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. http://www.compliancehome.com/news/FDA/12588.html Thu, 10 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12587.html The U.S. Food and Drug Administration announced that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products Total Body Formula and Total Body Mega Formula. The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products. On March 27, the FDA warned consumers not to purchase or use Total Body Formula in flavors Tropical Orange and Peach Nectar and Total Body Mega Formula in the Orange/Tangerine flavor of these products after receiving reports of adverse reactions in users in Florida and Tennessee (www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html). The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue. http://www.compliancehome.com/news/FDA/12587.html Sun, 06 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12546.html The U.S. Food and Drug Administration today announced the approval of Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children. Rotarix is a liquid and given in a two-dose series to infants from 6 to 24 weeks of age. Although the disease is usually self-limiting, rotavirus causes about 2.7 million cases of gastroenteritis in U.S. children each yearabout 55,000 to 70,000 of those require hospitalization; and between 20 and 60 deaths are attributed to it. Without vaccination, nearly every child in the United States would likely be infected at least once with rotavirus by age 5. There are many different strains of rotavirus. The vaccine protects against rotavirus gastroenteritis caused by the G1, G3, G4, and G9 strains. http://www.compliancehome.com/news/FDA/12546.html Sun, 06 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12545.html At the request of the U.S. Food and Drug Administration, on Wednesday U.S. Marshals seized more than $1,301,712 of dietary supplements from LG Sciences, LLC, of Brighton, Mich., because the products contain unapproved food additives and/or new dietary ingredients that cause the products to violate the law. Labeled as dietary supplements, the products are marketed for use by body builders. The dietary supplements seized were marketed and distributed on-line and in retail stores under the names Methyl 1-D, Methyl 1-D XL, and Formadrol Extreme XL. http://www.compliancehome.com/news/FDA/12545.html Fri, 04 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12536.html Dermestetics Cosmeceuticals, a company known to push the envelope with technologically advanced skin care products has seen a rise in sales due to the recent FDA reports on botulinum. Dermaxin, a powerful, topical wrinkle-relaxant and collagen-booster has been flying off the shelves as consumers seek new safe but effective alternatives to eliminate wrinkles. Dermaxin poses no risk of side effects such as damaged nerves or in extreme cases death that botulinum can impose. The U.S. Food and Drug Administration notified the public February 8, 2008 about harmful side effects of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B). These popular, medically administered injections have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses. Dermaxin is a safe alternative to treating the unwanted signs of aging including wrinkles, frown lines and loose http://www.compliancehome.com/news/FDA/12536.html Fri, 04 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12535.html The Lorillard Tobacco Company issued the following statement with regard to the passage of a bill by the House Committee on Energy and Commerce that would force the U.S. Food and Drug Administration (FDA) to regulate the tobacco industry. The Lorillard Tobacco Company opposes H.R. 1108 -- legislation that would force the FDA to regulate tobacco. While Lorillard fully supports reasonable federal regulation of the tobacco industry, the FDA already is overworked by Congress and is the wrong agency for the job. The challenges facing FDA are well documented. Adding a new industry for the FDA to oversee when it is struggling to fulfill its core mission is misguided. It will only compromise the health and safety of millions of Americans. http://www.compliancehome.com/news/FDA/12535.html Mon, 31 Mar 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12508.html Novartis Pharmaceuticals Corporation announced today the successful completion of a cooperative research and development agreement (CRADA) with the Food and Drug Administration (FDA), one of the first projects conducted under the FDA's Critical Path Initiative. The Critical Path Initiative was launched by FDA in 2004 to refine the science and processes through which FDA-regulated drugs, biologics, and devices are translated from a discovery or proof of concept to a medical product. The research produced under the CRADA led to a number of key achievements that will enhance the development and application of preclinical biomarkers to evaluate drug safety. In working together with FDA, we have demonstrated the progress that can be achieved in the biomarker field, and in the science of drug development in general, through public-private partnerships, according to John Orloff, MD, Senior Vice President, US Medical and Drug Regulatory Affairs at Novartis Pharmaceuticals Corporation. http://www.compliancehome.com/news/FDA/12508.html Wed, 26 Mar 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12493.html Congress has criticized the Food and Drug Administration (FDA) in the past year for not ensuring the safety of the nation's food, prescription drug and medical device supplies. Senior members of Congress have stated at various times, The health and safety of the American people is at risk... our food supply becomes more dangerous all the time... there is a fundamental breakdown for evaluating the safety of drugs... the FDA is badly broken. These sentiments are reflected in numerous national media stories describing a variety of FDA warnings on and recalls of food and drugs. In addition to elected officials, a scientific advisory panel recently reported that American lives are at risk due to the inability of FDA to oversee the safety of the food, drug and medical device supplies in the United States. http://www.compliancehome.com/news/FDA/12493.html Wed, 26 Mar 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12487.html Ingenuity Systems, provider of information solutions for life science researchers, announced it has achieved key milestones in the ongoing Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration. Significant progress has been made in several areas including the curation of new biomarker and toxicology content and the expansion of existing ontological classifications. These developments will advance the FDA towards its goal of rapidly identifying potential genomic 'fingerprints' that could be used to quickly and easily compare genomic data from submissions of drugs in the same class. Under the terms of the CRADA, Ingenuity Systems and the FDA will expand Ingenuity's content and software solutions to facilitate the research and regulatory review of biomarker, pharmacogenomic, and toxicogenomic data. The collaboration directly relates to the FDA's need to develop better tools for the review of genomic data. http://www.compliancehome.com/news/FDA/12487.html Wed, 26 Mar 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12486.html The U.S. Food and Drug Administration is advising consumers not to purchase or use Blue Steel or Hero products marketed as dietary supplements throughout the United States because they are considered unapproved drugs and have not been proven to be safe or effective. These products contain undeclared ingredients, which may dangerously affect a persons blood pressure level. These products are promoted and sold over the Internet for the treatment of erectile dysfunction (ED) and for sexual enhancement. Theyre touted as all natural and labeled as dietary supplements. However, Blue Steel and Hero products do not qualify as dietary supplements because they contain undeclared and unapproved substances that are similar in chemical structure to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for ED. http://www.compliancehome.com/news/FDA/12486.html