http://www.compliancehome.com/ ComplianceHome is one of the Web's largest library of resources for compliance management of HIPAA, SOX, FISMA, PCI, GLBA, FDA, 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 Thu, 25 Jun 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15795.html The first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets, 0.75 mg gets the approval from the U.S. Food and Drug Administration. The generic product will be available by prescription only for women ages 17 and under. http://www.compliancehome.com/news/FDA/15795.html Wed, 17 Jun 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15743.html The U.S. Food and Drug Administration is taking steps to improve contact lens safety by reminding consumers of the importance of following proper cleaning and storing procedures. Consumers who do not follow instructions for contact lens care and use increase their risk of serious eye infections that can lead to blindness. http://www.compliancehome.com/news/FDA/15743.html Mon, 15 Jun 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15730.html The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use. http://www.compliancehome.com/news/FDA/15730.html Sat, 30 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15650.html A renowned oncologist at the U.S. Food and Drug Administration, Richard Pazdur, M.D., is recognized by the worlds largest cancer professional society.The American Society of Clinical Oncology (ASCO) is presenting Pazdur with its Special Recognition Award for his achievements in cancer drug development and his outstanding service to the oncology community. Janet Woodcock, M.D., director of the FDAs Center for Drug Evaluation and Research said, This is a well-deserved award for a world-class oncologist. Rick has worked tirelessly to ensure that safe and effective therapies are available as quickly as possible to treat patients with cancer. The FDA is fortunate to have him leading our efforts in cancer drug development. http://www.compliancehome.com/news/FDA/15650.html Mon, 25 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15613.html A biodefense company developing medical countermeasures against biological and chemical threats PharmAthene, Inc announced that the Company has submitted its comprehensive regulatory strategy to the U.S. Food and Drug Administration (FDA) outlining the non-clinical and clinical development plans for licensure of SparVax(TM), a next generation recombinant protective antigen anthrax vaccine.The FDA submission is in response to recent amendments issued by the Department of Health and Human Services (HHS) on April 15th and 22nd, 2009, to solicitation number RFP BARDA 08-15, outlining a requirement to develop and procure 25 million doses of a next generation rPA anthrax vaccine for the country's civilian biomedical stockpile. http://www.compliancehome.com/news/FDA/15613.html Sat, 23 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15609.html Samsca tablets (tolvaptan) to treat hyponatremia, an abnormally low concentration of sodium in the blood have been approved by the U.S. Food and Drug Administration. With the approval of Samsca, physicians will have an additional tool to treat hyponatremia, said Norman Stockbridge, M.D., director of the Division of Cardiovascular and Renal Products in the FDAs Center for Drug Evaluation and Research. http://www.compliancehome.com/news/FDA/15609.html Wed, 13 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15528.html The consumers are being constantly advised by the Food and Drug Administration to stop using certain cosmetic Face Paint items labeled as distributed by Oriental Trading Co., Omaha, Neb., due to adverse event reports of skin reactions in children. These items were distributed nationwide. The FDA has learned of a cluster of adverse events in children exposed to various colors of the face paint. All exposures occurred on the same day at an organized event and included rashes, itchiness, burning sensation, and swelling where the face paints were applied. Significant microbial contamination was indicated in most of the products in testing by an FDA laboratory. http://www.compliancehome.com/news/FDA/15528.html Tue, 12 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15517.html The U.S. District Court for the Eastern District of Michigan, Southern Division, entered a consent decree that condemns and forfeits to the United States for destruction about $1.3 million worth of dietary supplements. The court order is the result of efforts by the federal government to protect consumers from products for which there is inadequate information to assure that they do not present a significant or unreasonable risk of illness or injury, said Michael Chappell, FDAs acting associate commissioner for regulatory affairs. It shows that the agency is prepared to use the necessary legal means to keep such products out of the marketplace. http://www.compliancehome.com/news/FDA/15517.html Fri, 08 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15506.html The U.S. Food and Drug Administration gives its approval to Avastin (bevacizumab) to treat patients with glioblastoma multiforme (GBM) when this form of brain cancer continues to progress following standard therapy. GBM is a rapidly progressing cancer that invades brain tissue and can impact physical activities and mental abilities. It affects about 6,700 persons in the United States every year. Following initial treatment with surgery, radiation, and/or chemotherapy, the cancer nearly always returns. http://www.compliancehome.com/news/FDA/15506.html Fri, 08 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15503.html A budget of $3.2 billion is being requested by the U.S. Food and Drug Administration to shield and promote the public health as part of the Presidents fiscal year (FY) 2010 budget a 19 percent increase over the current FDA fiscal year budget. The FY 2010 request, which covers the period of Oct. 1, 2009, through Sept. 30, 2010, includes increases of $295.2 million in budget authority and $215.4 million in industry user fees. http://www.compliancehome.com/news/FDA/15503.html Thu, 07 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15487.html The U.S. Food and Drug Administration (FDA) announced that it has approved a new manufacturing facility used to produce influenza virus vaccines. The facility is approved for seasonal influenza vaccine production and could be used for the production of vaccine against the new 2009 H1N1 influenza strain. As part of its overall pandemic influenza preparedness efforts, the FDA meets with vaccine manufacturers to guide the efficient establishment of influenza vaccine facilities that comply with agency requirements. The agency promptly reviews applications and manufacturing supplements that could increase both the number of manufacturers and the overall supply of vaccine. http://www.compliancehome.com/news/FDA/15487.html Fri, 01 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15455.html Consumers are being warned by the U.S. Food and Drug Administration to right away stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market. The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure. http://www.compliancehome.com/news/FDA/15455.html Fri, 01 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15450.html Incited by reports of serious adverse events, the U.S. Food and Drug Administration today announced that safety label changes, including a boxed warning, and a Risk Evaluation and Mitigation Strategy (REMS), are necessary for all botulinum toxin products. The agency said it took the action because of reports that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism, including unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids. http://www.compliancehome.com/news/FDA/15450.html Wed, 29 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15428.html A final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs is issued by the Food and Drug Administration.FDA action covered the products like Acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen. Acetaminophen is in a class by itself. The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers. http://www.compliancehome.com/news/FDA/15428.html Tue, 28 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15413.html In response to requests from the U.S. Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, has issued Emergency Use Authorizations (EUAs) to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances. The agency issued these EUAs for the use of certain Relenza and Tamiflu antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test. http://www.compliancehome.com/news/FDA/15413.html Mon, 27 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15401.html The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) recommended that consumers not eat raw alfalfa sprouts, including sprout blends containing alfalfa sprouts, until further notice because the product has been linked to Salmonella serotype Saintpaul contamination. Other types of sprouts have not been implicated at this time. Its been indicate through the investigations that the problem may be linked to contamination of seeds for alfalfa sprouts. Because suspect lots of seeds may be sold around the country and may account for a large proportion of the alfalfa seeds currently being used by sprout growers, and cases of illness are spread across multiple states, FDA and CDC are issuing this general advisory. http://www.compliancehome.com/news/FDA/15401.html Sun, 26 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15400.html Simponi (golimumab), a monthly treatment for adults with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis is approved by the U.S. Food and Drug Administration. All three conditions are chronic disorders in which the immune system attacks multiple joints, causing stiffness, pain, and restricted motion.Todays approval provides another treatment option for patients with these three debilitating disorders, said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia, and Rheumatology Products in the FDAs Center for Drug Evaluation and Research. And the steps were taking to minimize the risks will give patients the same level of safety protection required for other drugs in its class. http://www.compliancehome.com/news/FDA/15400.html Sun, 26 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15397.html New Envirosealed TECStation 1806 workstation of CCS-Inc. will be unveiled at this years Food Safety Summit in Washington, D.C. This rugged workstation is compact and allows for easy maintenance on the plant floor. The NEMA 4X Stainless Steel Enclosure is built to provide high-tech computing solutions in harsh environments. The unit has a 19 APR touchscreen display that is built to withstand predisposed environmental damage such as dust, dirt, chemicals, and scratching. APR touchscreen technology provides a clear, high-quality, non-reflective display. The stations dimensions allow for maximum screen exposure while minimizing the enclosures overall footprint. http://www.compliancehome.com/news/FDA/15397.html Wed, 22 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15355.html It is better explained by the findings of the U.S. Food and Drug Administration scientists and collaborators what part of the bird flu virus is seen by the immune system once a person becomes infected. As one result of this research, a protein of the bird flu virus called PB1-F2 was identified as a potentially potent target for attack by immune systems to stop the spread of the virus. Analysis of blood from patients recovering from the H5N1 avian influenza virus can lead to new tools for testing the potential protective activity of vaccines under development, said Karen Midthun, M.D., acting director of the FDAs Center for Biologics Evaluation and Research (CBER). The findings could also lead to new tests to detect infections, and improved therapies. http://www.compliancehome.com/news/FDA/15355.html Fri, 17 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15313.html The Oral Cancer Foundation called for the U.S. Senate to grant the U.S. Food and Drug Administration (FDA) authority over tobacco products in response to the tobacco industry's most aggressive marketing campaign targeted at women and girls in over a decade. All most two weeks ago the U.S. House of Representatives voted to give the FDA such authority. http://www.compliancehome.com/news/FDA/15313.html Wed, 15 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15285.html Coast IRB, LLC of Colorado Springs, Colo., has agreed to willingly stop some aspects of its clinical trial oversight operations due to serious concerns about the company's ability to protect human subjects participating in clinical trials, announced by the U.S Food and Drug Administration As per the records of the company, these actions may involve approximately 300 active human research studies conducted by some 3,000 clinical investigators. http://www.compliancehome.com/news/FDA/15285.html Sat, 11 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15272.html The U.S Food and Drug Administration modified its March 30, 2009, action warning manufacturers to stop the production and distribution of certain unapproved prescription opioids, to allow the continued marketing and distribution of one particular type of opioid -- a high concentrate morphine sulfate oral solution -- on an interim basis.This action is taken by FDA in response to concerns from patients and health care professionals in the palliative care community that the action taken on March 30 would cause a shortage of 20 mg/ml morphine sulfate oral solution. This product is widely used to alleviate pain in terminally-ill patients. The agency has determined that this dosage form is medically necessary, and should remain on the market until an approved alternative becomes available to the patients that need it. http://www.compliancehome.com/news/FDA/15272.html Thu, 09 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15255.html The manufacturer of the psoriasis drug Raptiva (efalizumab), Genentech, announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. Because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. By June 8, 2009, the company has decided to take this action. Raptiva will no longer be available in the United States. http://www.compliancehome.com/news/FDA/15255.html Wed, 08 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15252.html Engineering Regulatory Compliance. Attend two-day seminars, planned and delivered by subject matter experts who work in the field every day. Topics include: barrier isolation, product quality lifecycle implementation, packaging challenges, C&Q and validation inclusive of computer systems validation; applied risk management, global supply chain security, renovation, and GAMP GPG on PCS Ver. 2 and Calibration Guide, Ver. 2. http://www.compliancehome.com/news/FDA/15252.html Wed, 08 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15251.html The FDA made an announcement that manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and valuable information to the agency so that it may assess the risk level for each device type. Devices found by the FDA to be of high risk to consumers will be required to undergo the agencys most stringent premarket review process.The device types, which are listed in the Federal Register announcement posted, 25 in number were marketed in the U.S. prior to the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976. That law authorized the FDA to review new medical devices. Todays announcement is the first step towards completing the review of Class III device types predating the 1976 law, as was recommended by the U.S. Government Accountability Office (GAO) in a January 2009 report to Congress. http://www.compliancehome.com/news/FDA/15251.html Wed, 08 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15250.html U.S. Marshals at the request of the U.S. Food and Drug Administration, implemented an inspection warrant at Westco Fruit and Nuts Inc. (Westco/Westcott), an Irvington, N.J.-based company. Westco/Westcott did not provide access to distribution documents and declined to recall products after an FDA request. Regulated companies are required by law to grant FDA entry for inspection, as well as provide access to distribution records. The FDA does not have authority to compel companies to recall food products, such as peanuts. http://www.compliancehome.com/news/FDA/15250.html Wed, 08 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15249.html Coartem tablets (artemether and lumefantrine) for the treatment of severe, uncomplicated malaria infections in adults and children weighing at least five kilograms (approximately 11 pounds) have been approved by the U.S. Food and Drug Administration.Malaria is a global life-threatening disease, said Murray M. Lumpkin, M.D., deputy commissioner for International and Special Programs, FDA. It is encouraging to have new treatment available, particularly for children. http://www.compliancehome.com/news/FDA/15249.html Wed, 08 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15242.html With an immense increase in mans intellect, the technology that was once considered not viable is now being made available. Everyone has known someone that is in need of some type of surgery. Patients have become savvier in their search for treatment of whatever ails them. In doing that, doctors are constantly raising the bar when it comes to improving surgical procedures. One of the most groundbreaking procedures that is now being made available in a handful of hospitals across the country is the Gamma Knife procedure. http://www.compliancehome.com/news/FDA/15242.html Wed, 08 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15238.html The consumers are warned by FDA not to eat Strubs Norwegian Style Sliced Smoked Steelhead Salmon in 300 gram packages because of potential contamination with the bacterium Listeria monocytogenes. L. monocytogenes is a foodborne pathogen that can cause serious illness and death. The smoked steelhead salmon, distributed by West Side Foods Inc. of Bronx, N.Y., was imported from Canada, and 13 cartons were sold to three kosher retail stores in New York and Maryland. http://www.compliancehome.com/news/FDA/15238.html Wed, 08 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15237.html The U.S. Food and Drug Administration cleared for marketing a new, qick rapid test for the detection of influenza A/H5N1, a disease-causing subtype of the avian influenza A virus that can infect humans. The test, called AVantage A/H5N1 Flu Test, detects influenza A/H5N1 in throat or nose swabs collected from patients who have flu-like symptoms. The test identifies in less than 40 minutes a specific protein (NS1) that indicates the presence of the influenza A/H5N1 virus subtype. Tests previously cleared by the FDA to detect this influenza A virus subtype can take three or four hours to produce results. http://www.compliancehome.com/news/FDA/15237.html Mon, 06 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15220.html With immense pride, BiCOM Inc. presents its matchless Trans-palpebral and Tras-scleral tonometer Diaton to the American Society of Cataract and Refractive Surgery ASCRS on April 3th 8th, hosted by the city of San Francisco. With FDA approval, CE MARK and now Health Canada approval opens many international doors for BiCOM Inc., a global distributor of Diaton tonometers. Exhibition of Diaton tonometer to the members of American Society of Cataract and Refractive Surgery (ASCRS) presents the opportunity for BiCOM to display the incomparable unique qualities of trans-palpebral and tras-scleral Diaton tonometry tonometry through the Eyelid. http://www.compliancehome.com/news/FDA/15220.html Fri, 03 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15204.html The public is being alerted by the U.S. Food and Drug Administration (FDA) to a voluntary recall by Union International Food Company (Union City, Calif.) of the companys dry spice products. The recall is based on an investigation of an ongoing foodborne illness outbreak of Salmonella Rissen. This investigation is being conducted in collaboration with state health officials in California, Oregon, Nevada, Washington and the U.S. Centers for Disease Control and Prevention (CDC). The companys products are distributed in these states and Arizona. Lian How and Uncle Chen are the brand names under which the dry spices being recalled were sold primarily to ethnic restaurants, wholesalers, and retail outlets. At this time, the distribution of products appears confined to the western region of the country. http://www.compliancehome.com/news/FDA/15204.html Thu, 02 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15194.html Genentech, Inc. announced that the U.S. Food and Drug Administration Oncologic DrugsAdvisory Committee voted unanimously that the response seen with Avastin (bevacizumab) in people with previously treated glioblastoma is of sufficient magnitude to be reasonably likely to predict clinical benefit. The FDA is expected to make a decision whether to grant accelerated approval of Avastin for use in this most aggressive form of brain cancer by May 5, 2009. http://www.compliancehome.com/news/FDA/15194.html Wed, 01 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15192.html The first generic versions of Topamax tablets (topiramate) are approved by the U.S. Food and Drug Administration These tablets can be taken to prevent seizures. Generic drugs undergo a rigorous scientific review to ensure they will provide patients with the same dose of high quality, safe and effective active ingredient as the name brand product, said Gary Buehler, director of the Office of Generic Drugs in the Center for Drug Evaluation and Research. The FDA is committed to providing access to safe and effective generic drugs as soon as the law permits when a brand name drugs patents and exclusivities expire. http://www.compliancehome.com/news/FDA/15192.html Tue, 31 Mar 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15188.html Nine companies are warned by the U.S. Food and Drug Administration to stop manufacturing 14 unapproved narcotic drugs that are marketed in several dosage forms and are generally used to treat pain. The FDA's warning letters notified the companies they may be subject to enforcement action if they do not stop manufacturing and distributing prescription unapproved products that include high concentrate morphine sulfate oral solutions and immediate release tablets containing morphine sulfate, hydromorphone or oxycodone. This action does not include oxycodone capsules. http://www.compliancehome.com/news/FDA/15188.html Tue, 31 Mar 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15185.html Salmonella contamination in pistachio products sold by Setton Pistachio of Terra Bella Inc, Calif. is being investigated by the FDA and the California Department of Public Health (CDPH). The company has stopped all distribution of processed pistachios and will issue a voluntary recall involving approximately 1 million pounds of its products. Because the pistachios were used as ingredients in a variety of foods, it is likely this recall will impact many products. In addition, the investigation at the company is ongoing and may lead to additional pistachio product recalls. http://www.compliancehome.com/news/FDA/15185.html Tue, 31 Mar 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15173.html Afinitor oral tablets (everolimus) for the treatment of patients with advanced kidney cancer whose disease has progressed after treatment with other cancer therapies is approved by the U.S. Food and Drug Administration.The most common type of kidney cancer, renal cell cancer,originates in the lining of the small tubules in the kidney that filter waste products from the blood. The cancer is resistant to such standard treatments as radiation therapy and chemotherapy, and the initial treatment for most patients is surgical removal of the kidney. If the cancer is confined to the kidney, the five-year survival rate is 60 to 70 percent; but the survival rate is considerably lower after the cancer has spread to other parts of the body. http://www.compliancehome.com/news/FDA/15173.html Tue, 31 Mar 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15172.html IXIARO, a vaccine to prevent Japanese encephalitis (JE), is approved by the U.S. Food and Drug Administration. Encephalitis is caused by a mosquito-transmitted virus found mainly in Asia. IXIARO will be the only vaccine for JE available in the United States.This vaccine offers protection for individuals who travel to or live in areas where outbreaks are known to occur, said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research. http://www.compliancehome.com/news/FDA/15172.html Mon, 30 Mar 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15162.html A privately held specialty pharmaceutical company, Sagent Pharmaceuticals, Inc., announced that U.S. Food and Drug Administration has given approval of azithromycin for injection, a semi-synthetic, macrolide antibiotic that is used to treat a wide variety of bacterial infections. Sagent will offer azithromycin in a 500 mg vial for intravenous use. The Company anticipates the launch of azithromycin in April 2009. According to IMS, 2008 sales of azithromycin in the United States approximated $42 million. http://www.compliancehome.com/news/FDA/15162.html Mon, 30 Mar 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15161.html Dyax Corp. made an announcement that it has FDA has given a complete response letter pertaining to the Company's Biologic License Application for DX-88 (ecallantide) for the treatment of acute attacks of hereditary angioedema. The letter summarizes requirements for approval of DX-88 in this indication. Specifically, the FDA has requested submission of a Risk Evaluation and Mitigation Strategy and additional information with respect to the chemistry, manufacturing and controls section of the BLA. The letter does not include requirements for any additional clinical trials for approval of DX-88. http://www.compliancehome.com/news/FDA/15161.html Mon, 30 Mar 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15160.html The U.S. Food and Drug Administration classified as Class I its voluntary recall action initiated on February 11, 2009 of its BioGlide Ventricular Snap Shunt Catheter - the cerebral ventricular catheter component of a shunt for the treatment of hydrocephalus, announced Medtronic, Inc. FDA defines Class I recalls as, a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. This recall action (applicable to units in the United States, Ireland and Australia) involved the retrieval of unused product and safety notification of implanted product of these three catalog numbers of Medtronic Cerebral Ventricular Catheters. Approximately 3,000 catheters have been distributed between 2002 and 2009. It is estimated that there are 300 unused catheters. By 18, 2009, Medtronic completed contact with all users of these catheters. This was completed by visit from its field personnel delivering the http://www.compliancehome.com/news/FDA/15160.html Thu, 26 Mar 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15150.html A plan to submit a new drug application to the U.S. Food and Drug Administration in the second half of this year for approval to market VIAject for the treatment of diabetes is announced by Biodel Inc. VIAject is Biodel's investigational ultra-rapid-acting injectable human insulin intended for meal-time use by people with Type 1 and Type 2 diabetes. The NDA will be based upon results from multiple pharmacokinetic and pharmacodynamic studies as well as two completed Phase 3 studies of VIAject in patients with Type 1 and Type 2 diabetes. Last year at the 44th Annual Meeting of the European Association for the Study of Diabetes, preliminary results from the Phase 3 studies were reported. Biodel intends to seek approval for the 100 IU/cc liquid formulation of VIAject, which is bioequivalent to the two-part 25 IU/cc lyophilized powder formulation of VIAject that was used in the company's pivotal Phase 3 clinical trials. Biodel believes that results from both Phase 3 studies showed that VIAj http://www.compliancehome.com/news/FDA/15150.html Thu, 26 Mar 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15149.html Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that the Food and Drug Administration has responded to their Citizen Petition regarding COPAXONE (glatiramer acetate injection). The FDA declined to review the CP without comment on the approvability of any Abbreviated New Drug Application or New Drug Application for a glatiramer acetate injection drug product as it would be premature and inappropriate to do so at this time. By March 26, 2009 the agencys guidelines require a response to this Citizen Petition.The requests that Teva presented in its Citizen Petition is not yet acted upon by the FDA According to the Agency, it is not possible to render a final decision on specific requirements for approval of any ANDA or NDA for glatiramer acetate injection http://www.compliancehome.com/news/FDA/15149.html Wed, 25 Mar 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15136.html The U.S. Food and Drug Administration approved TYGACIL((tigecycline), for the treatment of adult patients with community-acquired bacterial pneumonia CABP, announced by Wyeth Pharmaceuticals, a division of Wyeth. CABP is caused by susceptible strains of indicated pathogens. TYGACIL was first approved by the FDA in 2005 for the treatment of complicated intra-abdominal infections (cIAI) and complicated skin and skin structure infections (cSSSI) caused by susceptible strains of indicated pathogens in adults. http://www.compliancehome.com/news/FDA/15136.html Mon, 23 Mar 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15108.html Consumers are warned by the U.S. Food and Drug Administration (FDA) not to consume any peanuts or peanut-derived products sold by Irvington, New Jersey-based Westco Fruit and Nuts Inc. (Westco/Westcott) due to possible Salmonella contamination. Peanuts in such products may have been distributed by the Peanut Corporation of America (PCA), which recalled the peanuts because of concern about Salmonella contamination.Westco/Westcott on March 23, 2009 was formally requested by FDA to voluntarily recollect all of its products containing peanuts from PCA because such products may be contaminated with Salmonella. Investigations by the FDA and the Centers for Disease Control and Prevention identified products from PCA's Blakely, Ga., facility as a source of the current Salmonella Typhimurium outbreak and led to PCA's recall of the peanuts.Between Nov. 19 and Dec. 30, 2008, Westco/Westcott received three shipments of Oil Roasted Salted Redskin Jumbo Peanuts from PCA's Blakely, Ga., facility. http://www.compliancehome.com/news/FDA/15108.html Mon, 23 Mar 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15107.html A US-based pharmaceutical company, Forest Laboratories Inc (NYSE : FRX), said on 20 March that the US Food and Drug Administration (FDA) has given its approval for its supplemental New Drug Application (sNDA) for Lexapro (escitalopram oxalate) for the acute and maintenance treatment of Major Depressive Disorder (MDD) in adolescents, aged 12-17 years. http://www.compliancehome.com/news/FDA/15107.html Mon, 23 Mar 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15103.html Billions of dollars equal a stunning loss in the Untied States economy suffers stunning loss due to medical costs and decrease in productivity. The culprit, osteoarthritis. A new therapy for home use that alleviates pain and inflammation with no side effects is however cleared by FDA. This therapy is the Q Laser System, a low level laser. This marks the first low level laser to be cleared by the FDA for over the counter use treating Osteoarthritis of the Hand. Osteoarthritis is currently not curable but an effective treatment can be provided to the millions of patients who are in its grip. To many people, it comes as exciting news that the FDA has recently approved a low-level laser treatment, the QLaser, for treating osteoarthritis in the hands. The Q1000 is a Class I laser device that has been classified by the FDA as a non-significant risk device as related to eye injuries, yet helps the body release endorphins (natural painkillers) reduce inflammation, increase circulation, help he http://www.compliancehome.com/news/FDA/15103.html Mon, 23 Mar 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15102.html The leader in quality management and regulatory compliance solutions, AssurX, Inc., has released a white paper titled: FDA Importer Guidance For Devices: Guidance on Good Importer Practices signals 2009 will be a year of a more focused, active agency for the medical device industry. This complimentary white paper throws light on the part of a broader effort by the FDA to place more responsibility for quality control on manufacturers and the agencys roadmap for producing safer products. http://www.compliancehome.com/news/FDA/15102.html Sat, 21 Mar 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15101.html The retailers and food service operators are cautioned by the U.S. Food and Drug Administration not to offer for sale oysters harvested between Feb. 24 and March 17, 2009, from Mississippi Area 2C, located in the Mississippi Sound portion of the Gulf of Mexico near Pass Christian, Miss. Customers in addition to this are advised not to eat such oysters. Consumers who are uncertain about the origin of oysters they currently have should contact the place of purchase to determine if the oysters are from the affected area as the Agency investigates an outbreak of norovirus illnesses associated with the oysters causing severe gastroenteritis in humans. At a restaurant in Chattanooga, Tenn, eleven individuals reported becoming sick after eating raw oysters. Test results by the Chattanooga-Hamilton County Health Department and Tennessee Department of Health confirmed that the patients were infected with norovirus. http://www.compliancehome.com/news/FDA/15101.html Fri, 20 Mar 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15094.html A strategic alliance with Code Refinery, a provider of FDA-compliant software and services is announced by Mi-Co. Mutually they aim to deliver custom software and data collection solutions for pharmaceutical, biotech and medical device customers. By working hand in hand Mi-Co and Code Refinery by will be in position to offer a broader range of software solutions and services to their customers and also to deliver additional return on investment. http://www.compliancehome.com/news/FDA/15094.html