Copyright 2012 Medical News TodayLatest Health News and Medical News posted throughout the day, every day.http://www.medicalnewstoday.com/sections/regulatoryaffairs/admin@medicalnewstoday.com (MNT Admin)editors@medicalnewstoday.com (MNT Editors)en-us Mon, 13 Feb 2012 01:00:00 PSThttp://www.medicalnewstoday.com/releases/241492.phphttp://www.medicalnewstoday.com/releases/241492.phpNeuroscientists at Case Western Reserve University School of Medicine have made a dramatic breakthrough in their efforts to find a cure for Alzheimer's disease. The researchers' findings, published in the journal Science, show that use of a drug in mice appears to quickly reverse the pathological, cognitive and memory deficits caused by the onset of Alzheimer's...Alzheimer's / Dementia Sun, 12 Feb 2012 08:00:00 PSThttp://www.medicalnewstoday.com/articles/241568.phphttp://www.medicalnewstoday.com/articles/241568.phpMethotrexate, a drug used to treat acute lymphoblastic leukemia, the most common childhood leukemia, is now also in short supply in the USA, along with several other lifesaving drugs. According to the FDA, vital lifesaving hospital drugs have not been so scarce in ten years. Methotrexate works by slowing down the rate at which cancer cells grow...Lymphoma / Leukemia / Myeloma Fri, 10 Feb 2012 10:00:00 PSThttp://www.medicalnewstoday.com/articles/241519.phphttp://www.medicalnewstoday.com/articles/241519.phpIn the U.S., in 2007, the prescription medication Vyvanse was introduced for the treatment of ADHD in children aged 6 to 12 years old by the US Food and Drug Administration (FDA). The following year the medication was approved to treat ADHD in adults, and approved in 2010 to treat adolescents aged 13 to 17 with ADHD...ADHD Fri, 10 Feb 2012 01:00:00 PSThttp://www.medicalnewstoday.com/releases/241403.phphttp://www.medicalnewstoday.com/releases/241403.phpA new study published in the journal Pharmacoepidemiology & Drug Safety reveals that benfluorex, a fenfluramine derivative drug used in France under the name Mediator®, is likely responsible for thousands of hospitalizations and deaths over a 30 year period. Benfluorex (Mediator®) was used in France from 1976 to 2009...Obesity / Weight Loss / Fitness Thu, 09 Feb 2012 02:00:00 PSThttp://www.medicalnewstoday.com/articles/241377.phphttp://www.medicalnewstoday.com/articles/241377.php A new study published this week shows there has been a big drop in levels of trans-fatty acids in the US bloodstream. From 2000 to 2009 it fell by 58%. This is the first time researchers from the US Centers from Disease Control and Prevention (CDC) have been able to measure trans-fats in human blood. They write about their findings in a letter to the Editor of JAMA...Nutrition / Diet Wed, 08 Feb 2012 15:00:00 PSThttp://www.medicalnewstoday.com/articles/241375.phphttp://www.medicalnewstoday.com/articles/241375.phpStomach acid drugs, known as PPIs (proton pump inhibitors), are linked to a higher risk of diarrhea caused by Clostridium difficile, a type of bacterium. Patients on PPIs who develop persistent diarrhea should be tested for CDAD (Clostridium difficile associated diarrhea), says the US Food and Drug Administration (FDA)...GastroIntestinal / Gastroenterology Fri, 03 Feb 2012 10:00:00 PSThttp://www.medicalnewstoday.com/articles/241159.phphttp://www.medicalnewstoday.com/articles/241159.phpPreparations are underway at the European Medicines Agency together with European Member States and the European Commission, for the introduction of the new pharmacovigilance legislation in July this year. The new legislation will represent the biggest change to the legal framework since The Agency was founded in 1995...Pharma Industry / Biotech Industry Fri, 03 Feb 2012 02:00:00 PSThttp://www.medicalnewstoday.com/articles/241133.phphttp://www.medicalnewstoday.com/articles/241133.php Scientists at the University of California, San Francisco (UCSF), argue that added sweeteners pose dangers to public health, and the government should regulate sugar in the same way as it regulates alcohol and tobacco. They set out their reasons for viewing sugar as "toxic" in a comment article published in Nature this week. First author Robert H...Nutrition / Diet Thu, 02 Feb 2012 08:00:00 PSThttp://www.medicalnewstoday.com/articles/241095.phphttp://www.medicalnewstoday.com/articles/241095.phpAn agreement, in principle, regarding proposed recommendations for the new reauthorization of a medical device user fee program, has been agreed by the FDA and the Medical Device Industry. If the recommendations go through, the FDA would be authorized to collect $595 million from the medical device industry in user fees for a five-year period, with adjustments according to annual inflation rates...Medical Devices / Diagnostics Thu, 02 Feb 2012 06:00:00 PSThttp://www.medicalnewstoday.com/articles/241093.phphttp://www.medicalnewstoday.com/articles/241093.phpThe following is an addendum to a FDA Letter to the Juice Products Association dated January 9, 2012. This information will be updated, as appropriate, on Friday of every week. January 27, 2012 The FDA is currently testing samples of orange juice shipments from all countries and manufacturers that import their products to the U.S...Regulatory Affairs / Drug Approvals Thu, 02 Feb 2012 00:00:00 PSThttp://www.medicalnewstoday.com/releases/241013.phphttp://www.medicalnewstoday.com/releases/241013.phpA new drug, MDV3100, is improving the survival rate in men with advanced prostate cancer, results of a large, phase III clinical trial show. The drug is designed to block a type of cellular receptor that drives progression of prostate cancer...Prostate / Prostate Cancer Wed, 01 Feb 2012 09:00:00 PSThttp://www.medicalnewstoday.com/articles/241044.phphttp://www.medicalnewstoday.com/articles/241044.phpBasal cell carcinoma is a form of skin cancer caused by regular sun exposure, or other ultraviolet radiation, which starts in the top layer of the skin (epidermis), is usually painless and grows slowly. The U.S. Food and Drug Administration just approved a new drug named Erivedge (vismodegib) for the treatment of adult patients with basal cell carcinoma, the most common type of skin cancer...Melanoma / Skin Cancer Wed, 01 Feb 2012 00:00:00 PSThttp://www.medicalnewstoday.com/articles/240944.phphttp://www.medicalnewstoday.com/articles/240944.phpOn Monday, the US Food and Drug Administration approved a new type of drug to treat adult patients with advanced basal-cell carcinoma, the most common type of skin cancer. The drug's generic name is vismodegib and was developed by the US part of Roche Holding AG. It will be sold in the US by Roche's South San Francisco-based Genentech under the brand name Erivedge...Regulatory Affairs / Drug Approvals Tue, 31 Jan 2012 13:00:00 PSThttp://www.medicalnewstoday.com/articles/240990.phphttp://www.medicalnewstoday.com/articles/240990.php Kalydeco has been approved by the Food And Drug Administration (FDA) to treat a vicious type of Cystic Fibrosis (CF). CF is a deadly recessive disease which targets the lungs, but can also harm the liver, pancreas, and intestine. It occurs from the unusual transport of chloride and sodium across the epithelium, causing mucus buildup in the lungs, and thick secretions...Cystic Fibrosis Tue, 31 Jan 2012 10:00:00 PSThttp://www.medicalnewstoday.com/articles/240983.phphttp://www.medicalnewstoday.com/articles/240983.phpThe key outcome of the FLABEL conference (Food Labeling to Advance Better Education for Life) in November 2011 was reported to be that even though nutrition labeling is commonly used throughout Europe, consumers pay insufficient attention and lack motivation to use them. FLABEL Scientific Advisor, Professor Klaus G...Nutrition / Diet Sun, 29 Jan 2012 00:00:00 PSThttp://www.medicalnewstoday.com/articles/240896.phphttp://www.medicalnewstoday.com/articles/240896.phpOn Friday, the US Food and Drug Administration finally approved Amylin Pharmaceutical's diabetes drug Bydureon, which provides glycemic control for diabetes type 2 in a once-weekly injection. The approval follows two earlier rejections in 2010, when the FDA asked the company to go back and carry out a new trial of the drug's effect on heart rhythm...Diabetes Fri, 27 Jan 2012 14:00:00 PSThttp://www.medicalnewstoday.com/articles/240892.phphttp://www.medicalnewstoday.com/articles/240892.phpThe US FDA has approved Inlyta (axitinib) for the treatment of advanced renal cell carcinoma, a type of kidney cancer, in patients with whom other drugs have not been effective, the FDA (Food and Drug Administration) announced today. Inlyta is made and marketed by pharmaceutical giant Pfizer Inc...Urology / Nephrology Fri, 27 Jan 2012 09:00:00 PSThttp://www.medicalnewstoday.com/articles/240871.phphttp://www.medicalnewstoday.com/articles/240871.php In the U.S., Keppra® has been approved as adjunctive therapy for partial onset seizures in adults and children aged four years and older with epilepsy. However the UCB recently announced that the U.S. Food and Drug Administration (FDA) has now approved to lower the age restriction to include infants from the age of one month and older with epilepsy. Professor Dr...Epilepsy Mon, 23 Jan 2012 04:00:00 PSThttp://www.medicalnewstoday.com/articles/240637.phphttp://www.medicalnewstoday.com/articles/240637.php The British Association of Aesthetic Plastic Surgeons (BAAPS) is calling on the UK government to ban cosmetic surgery advertising and tighten up industry regulations, including carrying annual checks on surgeons. The association has long voiced its objection to the use of "marketing gimmicks" to promote cosmetic surgery and what it sees as the lax regulation of the industry...Cosmetic Medicine / Plastic Surgery Mon, 23 Jan 2012 00:00:00 PSThttp://www.medicalnewstoday.com/releases/240566.phphttp://www.medicalnewstoday.com/releases/240566.phpThe impact of efforts by the U.S. Food and Drug Administration to notify the general public and health care providers about unanticipated risks from approved medications has been "varied and unpredictable," according to a systematic review of published studies about FDA warnings and alerts over the last 20 years...Regulatory Affairs / Drug Approvals Sat, 21 Jan 2012 00:00:00 PSThttp://www.medicalnewstoday.com/releases/240548.phphttp://www.medicalnewstoday.com/releases/240548.phpThe U.S. Food and Drug Administration (FDA) recently recommended that clinicians be more conservative when they prescribe chronic kidney disease (CKD) patients with drugs that treat red blood cell deficiencies. But the drug label's recommendations fall short, according to two commentaries appearing in an upcoming issue of the Clinical Journal of the American Society Nephrology (CJASN)...Urology / Nephrology Wed, 11 Jan 2012 12:00:00 PSThttp://www.medicalnewstoday.com/articles/240219.phphttp://www.medicalnewstoday.com/articles/240219.phpThe FDA (Food and Drug Administration) released a letter to orange juice processing companies regarding their take on the recent discovery of carbendazim in orange juice. Carbendazim, molecular formula C9H9N3O2, is a fungicide (chemical that destroy fungi that are harmful to crops). This particular fungicide, carbendazim, has been cleared to be used on crops in most parts of the world...Nutrition / Diet Thu, 05 Jan 2012 00:00:00 PSThttp://www.medicalnewstoday.com/articles/239929.phphttp://www.medicalnewstoday.com/articles/239929.phpIn a bid to protect an important class of antibiotics for treating humans and reduce the development of drug resistance, the US Food and Drug Administration has banned certain uses of cephalosporins in food-producing animals. The federal agency announced on Wednesday that the prohibition order comes into effect on 5 April...Regulatory Affairs / Drug Approvals Wed, 04 Jan 2012 00:00:00 PSThttp://www.medicalnewstoday.com/releases/239835.phphttp://www.medicalnewstoday.com/releases/239835.phpAcetaminophen is one of the most commonly used pain and fever relievers for infants and children and is safe and effective when used as directed...Pain / Anesthetics Tue, 03 Jan 2012 01:00:00 PSThttp://www.medicalnewstoday.com/releases/239805.phphttp://www.medicalnewstoday.com/releases/239805.phpThe U.S. Food and Drug Administration approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products. This new shared system will replace the individual REMS and allow prescribers and pharmacies to enroll into just one system, easing the burden on the health care system...Pain / Anesthetics