November 1, 2008FDA Panel Accepts Findings on BPA - Washington Post FDA Panel Accepts Findings on BPA - Washington Post
The Food and Drug Administration made mistakes when determining that a widely used chemical found in baby bottles and other plastics was harmless and the agency should redo its risk assessment, an FDA advisory panel ruled yesterday. But the report's Source: www.washingtonpost.com Cancer therapy raises questions about FDA's reviews - Boston Globe After a surgeon removed a cancerous lump from Karen Medlock's breast in November, he recommended radiation, a routine next step meant to keep cancer from recurring. But he did not send her for the kind of radiation most women have received for Source: www.boston.com Spectrum Pharmaceuticals Files Supplemental New Drug Application with - MSN MoneyCentral Spectrum Pharmaceuticals, Inc., SPPI today announced that it has filed with the FDA the supplemental NDA for FUSILEV ™ (levoleucovorin) for injection in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. FUSILEV Source: news.moneycentral.msn.com FDA clearance on treatments doesn't mean they work - Seattle Times After a surgeon removed a cancerous lump from Karen Medlock's breast in November, he recommended radiation, a routine next step meant to keep cancer from recurring. But he did not send her for the kind of radiation most women have received for Source: seattletimes.nwsource.com UPDATE 1-Barr gets FDA nod for oral contraceptive - Reuters Oct 27 (Reuters) - Barr Pharmaceuticals Inc (BRL.N: Quote , Profile , Research , Stock Buzz ) said the U.S. regulators approved an oral contraceptive made by its unit Duramed Pharmaceuticals Inc. Barr, which agreed to be bought by Israel-based Teva Source: www.reuters.com FDA Approves Duramed's LoSEASONIQUE(R) Oral Contraceptive - MSN MoneyCentral Duramed to Launch First Lower-Dose, Extended-Cycle Oral Contraceptive for the Prevention of Pregnancy MONTVALE, N.J. , Oct. 27 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. BRL today announced that the U.S. Food and Drug Administration (FDA Source: news.moneycentral.msn.com Pfizer's TOVIAZ(TM) (fesoterodine fumarate) Receives FDA Approval for - MSN MoneyCentral Pfizer Inc said today that the U.S. Food and Drug Administration (FDA) approved TOVIAZ ™ (fesoterodine fumarate) extended release tablets for the treatment of overactive bladder (OAB) symptoms. New once-daily TOVIAZ can significantly reduce the Source: news.moneycentral.msn.com FDA accepts call for more research on BPA hazards - Minneapolis Star Tribune WASHINGTON - The Food and Drug Administration made mistakes when determining that a widely used chemical found in baby bottles and other plastics was harmless and the agency should redo its risk assessment, an FDA advisory panel ruled Friday. But the Source: www.startribune.com FDA Findings On BPA Are Misleading, Experts Claim - Eflux Media FDA Findings On BPA Are Misleading, Experts Claim - Eflux Media
An FDA advisory board voted unanimously Friday to say that the agency disregarded significant evidence about bishpenol A safety. Federal regulators issued a draft report in August which said that levels of bisphenol A found in baby bottles and other Source: www.efluxmedia.com Gilead Announces Two-Year Data from Pivotal Phase III Studies - MSN MoneyCentral Gilead Sciences, Inc. GILD today announced the presentation of two-year (96-week) data from two Phase III pivotal clinical trials, Studies 102 and 103, evaluating the safety and efficacy of once-daily Viread ® (tenofovir disoproxil fumarate) among Source: news.moneycentral.msn.com Anadys Pharmaceuticals Announces Single Dose Safety and - MSN MoneyCentral Phase I Clinical Data and Additional Preclinical Results for Non-Nucleoside HCV Polymerase Inhibitor Being Presented at AASLD SAN DIEGO , Nov. 1 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. ANDS announced today the results of a Phase I Source: news.moneycentral.msn.com FDA urged to reassess chemical - Tacoma News Tribune WASHINGTON – The Food and Drug Administration made mistakes when determining that a widely used chemical found in baby bottles and other plastics was harmless, and the agency should redo its risk assessment, an FDA advisory panel ruled Friday. But Source: www.thenewstribune.com FDA urged to reassess chemical - Tacoma News Tribune FDA urged to reassess chemical - Tacoma News Tribune
WASHINGTON – The Food and Drug Administration made mistakes when determining that a widely used chemical found in baby bottles and other plastics was harmless, and the agency should redo its risk assessment, an FDA advisory panel ruled Friday. But Source: www.thenewstribune.com Growth hormones not for normal kids - Chicago Sun-Times Water-cooler talk in a doctor's office often revolves around patients. Not long ago a colleague of mine, a pediatric endocrinologist, mentioned that she had met with parents who wanted to put their child on growth hormone, a drug used to treat short Source: www.suntimes.com FDA Findings on BPA Safety Questioned Again by a Panel of - Eflux Media A panel of toxicology experts has urged the FDA to rethink its conclusions on bisphenol A, a chemical found in plastic food and drink containers. The panel included environmental health, toxicology and statistics experts from three major universities Source: www.efluxmedia.com New Drug to Deal with Overactive Bladder - Eflux Media Patients who suffer from overactive bladder can now hope for better as the FDA approved a new prescription drug called Toviaz that deals with overactive bladder in adults. Two 12-week randomized placebo-controlled studies, involving a total of 554 Source: www.efluxmedia.com India's Ranbaxy reports $96 mln quarterly loss - International Herald Tribune MUMBAI, India : Ranbaxy Laboratories Ltd., India's largest drug maker, on Friday reported a loss of 3.94 billion rupees ($96 million) for the July to September quarter, stung by steep foreign exchange losses and an import ban by the Food and Drug Source: www.iht.com FDA Running Extortion Racket: Natural Supplement Companies Threatened - OpEdNews.com (NaturalNews) NaturalNews has learned the U.S. Food and Drug Administration is running a criminal extortion racket designed to drain cash from health supplement companies and shift it into the pockets of top FDA contractors. This organized crime Source: www.opednews.com October 31, 2008FDA Approves Toviaz To Treat Overactive Bladder - eMaxHealth.com FDA Approves Toviaz To Treat Overactive Bladder - eMaxHealth.com
The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency Source: www.emaxhealth.com FDA accepts call for more research on BPA hazards - Minneapolis Star Tribune WASHINGTON - The Food and Drug Administration made mistakes when determining that a widely used chemical found in baby bottles and other plastics was harmless and the agency should redo its risk assessment, an FDA advisory panel ruled Friday. But the Source: www.startribune.com CORRECTED - PREVIEW-Drugmakers seek lawsuit limits at top US court - Reuters WASHINGTON, Oct 31 (Reuters) - The U.S. Supreme Court hears arguments on Monday in a closely watched case that could limit liability claims against drugmakers if one of their medicines causes harm. The case pits drug giant Wyeth (WYE.N: Quote Source: www.reuters.com Frederick Baron (1947-2008) - Wall Street Journal A scourge of big business, plaintiffs lawyer Frederick Martin Baron turned asbestos litigation into a lucrative machine and, for better or worse, helped invent the mass tort industry. His success in winning hundreds of asbestos cases made him a Source: online.wsj.com Spiration device gets FDA approval - Seattle Times Spiration said Friday that the U.S. Food and Drug Administration approved the use of its technology to control prolonged air leaks of the lung. The Redmond company said the agency granted a rare Humanitarian Device Exemption from a more rigorous Source: seattletimes.nwsource.com Medical Experts Endorse Critical Review Of FDA Report - CNN Money GAITHERSBURG, Md. -(Dow Jones)- A U.S. Food and Drug Administration panel endorsed a review that called the agency's report on a chemical found in plastic food containers inadequate. A review released Wednesday was sharply critical of the FDA's Source: money.cnn.com FDA Panel Accepts Findings on BPA - Washington Post The Food and Drug Administration made mistakes when determining that a widely used chemical found in baby bottles and other plastics was harmless and the agency should redo its risk assessment, an FDA advisory panel ruled yesterday. But the report's Source: www.washingtonpost.com Cephalon Gets FDA Nod for Cancer Drug - Street.Com Cephalon ( CEPH Quote - Cramer on CEPH - Stock Picks ) on Friday received a second approval from the Food and Drug Administration for its cancer drug Treanda, this time as a treatment for patients with non-Hodgkins lymphoma (NHL). Treanda is the only Source: www.thestreet.com Power Medical Interventions, Inc. Receives Nasdaq Listing Deficiency - MSN MoneyCentral LANGHORNE, Pa., Oct. 24, 2008 (GLOBE NEWSWIRE) -- Power Medical Interventions(r), Inc. (Nasdaq:PMII), a leader in developing and commercializing Intelligent Surgical Instruments(tm), announced today that it received from the Nasdaq Stock Market a Source: news.moneycentral.msn.com Experts say FDA findings on compound misleading - CNN WASHINGTON (CNN) -- A panel of experts accused the Food and Drug Administration of creating "a false sense of security" with its assessment that a compound used to make food and beverage containers poses no immediate health risks. Bisphenol A is Source: www.cnn.com Cephalon Gets FDA Nod for Cancer Drug - Street.Com Cephalon Gets FDA Nod for Cancer Drug - Street.Com
Cephalon ( CEPH Quote - Cramer on CEPH - Stock Picks ) on Friday received a second approval from the Food and Drug Administration for its cancer drug Treanda, this time as a treatment for patients with non-Hodgkins lymphoma (NHL). Treanda is the only Source: www.thestreet.com UPDATE 1-PREVIEW-Drugmakers seek lawsuit limits at top US court - Reuters WASHINGTON, Oct 31 (Reuters) - The U.S. Supreme Court hears arguments on Monday in a closely watched case that could limit liability claims against drugmakers if one of their medicines causes harm. The case pits drug giant Wyeth (WYE.N: Quote Source: www.reuters.com Cephalon Receives FDA Approval for Its lymphatic Cancer Drug Treanda - RTT News Amendment: Cephalon Swings To Q3 Profit; Lifts FY 08 Outlook, Guides FY09 Amendment: Cephalon Swings To Q3 Profit; Lifts FY 08 Outlook, Guides FY09 (RTTNews) - Friday, biopharmaceutical company Cephalon, Inc., (CEPH: News ) announced that its drug Source: www.rttnews.com Drugmakers could win lawsuit limits at top court - Reuters WASHINGTON (Reuters) - The U.S. Supreme Court hears arguments on Monday in a closely watched case that could limit liability claims against drugmakers if one of their medicines causes harm. The case pits drug giant Wyeth (WYE.N: Quote , Profile Source: www.reuters.com FDA Urged to Reexamine BPA - Washington Post The Food and Drug Administration made mistakes when it said last month that a widely used chemical found in baby bottles and a wide array of plastics was harmless and it should redo its risk assessment, an FDA advisory panel ruled today. The FDA Source: www.washingtonpost.com Consumer Group Seeks FDA Ban on Avandia - BusinessWeek THURSDAY, Oct. 30 (HealthDay News) -- The diabetes drug Avandia should be banned in the United States because it can cause death from liver failure and poses many other life-threatening risks that greatly outweigh its benefits, the advocacy group Source: www.businessweek.com Transvaginal Placement of Surgical Mesh Transvaginal Placement of Surgical Mesh
Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence. Keeping Watch Over Direct-to-Consumer Ads FDA regulates direct-to-consumer advertising for prescription drugs, working to ensure that ads are truthful, balanced, and accurate. Recalls and Safety Alerts: Increased Risk of Death in Elderly Patients Taking Conventional Antipsychotics for Dementia FDA is requiring that "conventional" antipsychotic drugs carry a boxed warning stating that these drugs increase the risk of death when they are used to treat dementia-related psychosis in elderly patients. This category includes such drugs as Haldo... US FDA clears Schwarz Pharma, Pfizer bladder drug - Guardian Unlimited US FDA clears Schwarz Pharma, Pfizer bladder drug - Guardian Unlimited
WASHINGTON, Oct 31 (Reuters) - A new drug made by Schwarz Pharma to treat patients with overactive bladders won approval from U.S. health officials on Friday. The drug, Toviaz, is manufactured by Germany's Schwarz Pharma and distributed by Pfizer Inc Source: www.guardian.co.uk FDA clears new drug for overactive bladder - MSN MoneyCentral WASHINGTON (AP) - The Food and Drug Administration approved a new drug Friday to treat patients with overactive bladder, a disorder that causes frequent, uncontrollable urination. Toviaz, made by German manufacturer Schwarz Pharma, helps relax the Source: news.moneycentral.msn.com Pfizer's TOVIAZ(TM) (fesoterodine fumarate) Receives FDA Approval for - MSN MoneyCentral Pfizer Inc said today that the U.S. Food and Drug Administration (FDA) approved TOVIAZ ™ (fesoterodine fumarate) extended release tablets for the treatment of overactive bladder (OAB) symptoms. New once-daily TOVIAZ can significantly reduce the Source: news.moneycentral.msn.com Consumer Group Urges FDA to Ban Glaxo’s Avandia over Liver Failure - Eflux Media Consumer group Public Citizen on Thursday asked the Food and Drug Administration to ban GlaxoSmithKline PLC’s diabetes drug Avandia over fears that the drug might cause liver failure. After eight years on the market, the world’s best-selling Source: www.efluxmedia.com Consumer Group Petitions FDA To Ban Avandia - Redorbit.com Public Citizen, a consumer advocate group, has called on the U.S. to ban sales and distribution of the diabetes drug Avandia due to certain risks found to be linked with the drug. New research released by Public Citizen about the drug, used to treat Source: www.redorbit.com October 30, 2008Mexican Vanilla With Coumarin: No Bargain Mexican Vanilla With Coumarin: No Bargain
Beware of Mexican vanilla that contains coumarin, a toxic substance banned in the United States. Current Drug Shortage: Proglycem (diazoxide) oral suspension Current Drug Shortage: Proglycem (diazoxide) oral suspension
Teva is managing inventory and can provide product from their emergency supply. Orders for Proglycem can be made during regular business hours (8am to 5pm Eastern, Monday through Friday) by calling Customer Service at 800-545-8800. Emergency requests can be made after hours by calling 800-795-2652 Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 See Web site for additional information on this current drug shortage FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31. FDA Preemption and Patient Welfare in Wyeth v. Levine - American Enterprise Institute FDA Preemption and Patient Welfare in Wyeth v. Levine - American Enterprise Institute
Click here to view this Outlook as an Adobe Acrobat PDF. Wyeth v. Levine , which will be heard by the Supreme Court on November 3, 2008, is a lawsuit at the boundary between the state tort liability system and Food and Drug Administration (FDA Source: www.aei.org FDA Warns Bayer on Two Aspirin Products - Wall Street Journal WASHINGTON -- Pharmaceutical giant Bayer AG has received warnings from federal regulators for illegally marketing two unapproved over-the-counter medicines combining aspirin with dietary supplements. Bayer's "Bayer Aspirin With Heart Advantage" and Source: online.wsj.com Panel Criticizes FDA Bisphenol A Report - Medscape News October 30, 2008 — The controversy over the plastic chemical bisphenol A is heating back up, with a panel of scientists criticizing an FDA draft report on bisphenol A safety. Bisphenol A, also called BPA, is a chemical found in polycarbonate Source: www.medscape.com ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets (October 15) ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets (October 15)
ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side. Outsmarting Poison Ivy and Other Poisonous Plants Poison ivy and other poisonous plants are a hazard all year round. Here are tips for preventing and treating the itchy rash and blisters. Use Caution With Ayurvedic Products The presence of heavy metals in some Ayurvedic products makes them potentially harmful. Russell Stover Candies, Inc. Issues Hazelnut Allergy Alert for the 2 7/8 Oz Size Of Private Reserve Assorted Chocolates (October 9) The recalled product was distributed in the following states and cities: Texas, California, Louisiana, North Carolina, South Carolina, Virginia, Tennessee; Southaven, Mississippi; Billings, Montana; Sparks, Nevada; and Madison Heights, Michigan. An investigation determined 29 boxes of this candy may have been purchased by consumers, and up to another 188 boxes may have reached retail store locations. All the retail stores have been contacted to have the suspected product removed from the shelves. Arnold Foods Company, Inc. Issues Allergy Alert on Undeclared Nuts in Brownberry Whole Grains Bread 100 Percent Whole Wheat (October 8) The product being recalled has a green twist tie with a code date of "Oct 11" printed on the bread bag. No other Arnold brand or Brownberry brand products are affected. Consumer Alert: Possible Botulism Contamination in Frozen Salted Croaker (October 6) New York State Agriculture Commissioner alerted consumers not to eat Frozen Salted Croaker distributed by YS Trading Corp, Long Island City, New York because the product was uneviscerated. The Frozen Salted Croaker was sold in Hicksville, New York, Flushing, New York, and New Jersey in un-coded, unlabeled plastic bags. Is It Really FDA Approved? Some marketers say their products are "FDA approved", but how can you know for sure? HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections. Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System (October 24) Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. Outsmarting Poison Ivy and Other Poisonous Plants Outsmarting Poison Ivy and Other Poisonous Plants
Poison ivy and other poisonous plants are a hazard all year round. Here are tips for preventing and treating the itchy rash and blisters. Safety Concerns and Labeling Changes for Psoriasis Drug Raptiva FDA has received reports of serious infections leading to hospitalizations and deaths in people who use Raptiva. Mars Petcare US Issues Voluntary Recall of a Limited Number of Bags of SPECIAL KITTY Gourmet Sold at Wal-Mart locations in Fifteen States due to Potential Salmonella Contamination Mars Petcare US today announced a voluntary recall of a limited number of bags of SPECIAL KITTY Gourmet Blend dry cat food sold at Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia. The pet food is being voluntarily recalled following a positive test result indicating a potential contamination with Salmonella. ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets (October 15) ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side. Health Information Advisory on Infant Formula In response to reports of contaminated milk-based infant formula manufactured in China, FDA issued a Health Information Advisory on September 12, 2008. Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated) Updated letter on this current drug shortage Draft Guidance on Genetically Engineered Animals The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals. The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk (October 20) The Hartz Mountain Corporation, Secaucus, NJ is voluntarily recalling one specific lot of Hartz Chicken-Basted Rawhide Chips due to concerns that one or more bags within the lot are potentially contaminated with Salmonella. Hartz is fully cooperating with the US Food and Drug Administration in this voluntary recall. Keeping Watch Over Direct-to-Consumer Ads FDA regulates direct-to-consumer advertising for prescription drugs, working to ensure that ads are truthful, balanced, and accurate. Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection See Web site for additional information Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection
See Web site for additional information on this current drug shortage Recalls and Safety Alerts: Serious Complications from Using Recombinant Bone Morphogenetic Protein in the Cervical Spine FDA is alerting healthcare professionals about reports of life-threatening complications from the use of recombinant human Bone Morphogenetic Protein (rhBMP) in cervical spine fusion. Although FDA has approved two rhBMP products for very specific me... Outsmarting Poison Ivy and Other Poisonous Plants Poison ivy and other poisonous plants are a hazard all year round. Here are tips for preventing and treating the itchy rash and blisters. Is It Really FDA Approved? Some marketers say their products are "FDA approved", but how can you know for sure? Recalls and Melamine Contamination FDA has increased inspections and product testing in response to the melamine contamination problem that originated in Chinese dairy products. Slow and steady upends the race - Chicago Tribune Slow and steady upends the race - Chicago Tribune
Stepped-up scrutiny by federal regulators is holding up the release of a string of drugs to treat such common ailments as high cholesterol and osteoporosis. At least 10 drugs for treating a range of ailments from rheumatoid arthritis and heart Source: www.chicagotribune.com HHS/FDA Grants Tentative Approval For 75th Generic Anti-Retroviral - eMaxHealth.com HHS/FDA Grants Tentative Approval For 75th Generic Anti-Retroviral - eMaxHealth.com
The Food and Drug Administration within the U.S. Department of Health and Human Services (HHS) has reached the milestone of the 75th anti-retroviral generic drug approved or tentatively approved as part of President Bush’s Emergency Plan for AIDS Source: www.emaxhealth.com FDA May Revise Warning for Antismoking Drug - Wall Street Journal WASHINGTON -- The Food and Drug Administration said it may upgrade warnings on the Pfizer Inc. antismoking drug Chantix after a nonprofit safety group cited a new spate of road-traffic accidents and seizures involving people on the drug. The Source: online.wsj.com FDA denies ignoring harm in bottle chemical - Reuters India WASHINGTON (Reuters) - U.S. regulators said on Wednesday they did not ignore evidence showing possible harm from a chemical used in many plastic products, including baby bottles and food containers. A panel of outside experts convened by the Food and Source: in.reuters.com Some at FDA Oppose Rules Against Suing Drugmakers - Washington Post Top scientists and career employees at the Food and Drug Administration opposed agency regulations that weaken consumers' ability to sue drugmakers, congressional investigators said Wednesday. At issue is language in a drug labeling rule from 2006 Source: www.washingtonpost.com Report: FDA officials opposed drug suit policy - Forbes Top scientists and career employees at the Food and Drug Administration opposed agency regulations that weaken consumers' ability to sue drug makers, congressional investigators said Wednesday. At issue is language in a drug labeling rule from 2006 Source: www.forbes.com FDA Gave Drugmakers Legal Shield Over Objections (Update3) - Bloomberg Oct. 29 (Bloomberg) -- Political appointees at the Food and Drug Administration adopted rules that help shield drugmakers from patients' lawsuits over opposition from the agency's staff, a House report says Appointees of President George W. Bush Source: www.bloomberg.com FDA staff, White House disagreed on drug lawsuits, papers show - Los Angeles Times Reporting from Washington -- The top staff regulators who oversaw the approval of new drugs in this country objected to the Bush administration's drive to shield drug makers from being sued, according to internal documents released Wednesday by Rep Source: www.latimes.com Is BPA safe or not? Even government is confused - Houston Chronicle The government on Wednesday cleared a prominent outside adviser of conflict-of-interest allegations involving his findings on whether a chemical used to make plastic food containers poses a health risk. Officials, however, recommended that University Source: www.chron.com BPA Ruling Flawed, Panel Says - Washington Post The Food and Drug Administration ignored scientific evidence and used flawed methods when it determined that a chemical widely used in baby bottles and in the lining of cans is not harmful, a scientific advisory panel has found. In a highly critical Source: www.washingtonpost.com October 29, 2008FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report FDA Statement on Release of Bisphenol A (BPA) Subcommittee Report
The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31. Barry Callebaut USA LLC Issues Allergen Alert on Undeclared Milk Protein in Kroger Value Semi Sweet Chocolate Chips (October 10) Barry Callebaut USA LLC is conducting a voluntary recall on its product sold by Kroger Stores under the brand "Kroger Value Semi Sweet Chocolate Chips", 12 oz., UPC Code is 11110–86603 and "sell by" date May 30, 2010, as the product may contain undeclared milk protein. The "sell by" date is found printed in black on the end of the bag. People with allergies or severe sensitivity to milk protein may be at risk of serious or life-threatening allergic reaction if they consume this product. HHS/FDA Grants Tentative Approval for 75th Generic Anti-Retroviral Drug as Part of President's Emergency Plan for AIDS Relief Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections. Recalls and Safety Alerts: Warning on Tendon Injuries with Fluoroquinolone Antibiotics FDA has asked that a boxed warning be added to the prescribing information for fluoroquinolone antibiotics. The warning will remind healthcare professionals that patients taking these drugs may experience an increased risk of tendinitis and tendon r... Nonna's Real Italiana Cuccine Issues an Allergy Alert on Undeclared Milk, Soy, and Wheat in Stuffed Artichokes (October 22) This product is distributed through retailers in the Greater New Orleans area including the Northshore from October 8, 2008 to October 17, 2008. The product is individually wrapped in clear plastic wrap bearing the label: "STUFFED ARTICHOKE, Net Wt. 15 oz., NONNA'S REAL ITALIANA CUCCINE". Consumer Alert: Possible Botulism Contamination in Frozen Salted Croaker (October 6) New York State Agriculture Commissioner alerted consumers not to eat Frozen Salted Croaker distributed by YS Trading Corp, Long Island City, New York because the product was uneviscerated. The Frozen Salted Croaker was sold in Hicksville, New York, Flushing, New York, and New Jersey in un-coded, unlabeled plastic bags. Consumer Alert: Undeclared Sulfites in Shad Raisins (October 6) New York State Agriculture Commissioner alerted consumers that Fatima Brothers Inc. of Maspeth, New York is recalling Shad Raisins due to the presence of undeclared sulfites. The recalled Shad Raisins were packaged in uncoded, 7-ounce plastic bags. Shad Raisins were distributed in New York City. Lotte USA, Inc. Initiates Nationwide Recall of Koala's March Creme filled Cookies Lotte USA, Inc., Battle Creek, MI initiated a recall of all Koalas' March Cookies on September 29, 2008 because they were produced in China and they may be contaminated with melamine. The products are packaged in a plastic overwrap. Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection
See Related information section for posted letter October 2008 Patient Safety News October 2008 Patient Safety News
Patient Safety News is a video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Safety Concerns and Labeling Changes for Psoriasis Drug Raptiva FDA has received reports of serious infections leading to hospitalizations and deaths in people who use Raptiva. Thoratec HeartMate II Left Ventricular Assist System Device correction because the wear and fatigue of the percutaneous lead connecting the blood pump with the system controller may cause serious injury or death. Draft Guidance on Genetically Engineered Animals The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals. In-Body Pediatric Devices Pose Unique Challenges Implantable pediatric medical devices are exciting examples of cutting-edge medical technology. But they require special considerations on the part of parents, health professionals, and scientists who design devices. Over The Counter Cough and Cold Medications Product labels being modified to state "do not use" in children under 4 years of age. Recalls and Safety Alerts: CT Scanning May Cause Malfunction of Electronic Medical Devices Recalls and Safety Alerts: CT Scanning May Cause Malfunction of Electronic Medical Devices
FDA is alerting healthcare professionals that the x-rays emitted during CT exams may cause some electronic medical devices to malfunction. These malfunctions are different from those related to MRI scanning, which are caused by strong electrical and... Recalls and Safety Alerts: Serious Complications from Using Recombinant Bone Morphogenetic Protein in the Cervical Spine FDA is alerting healthcare professionals about reports of life-threatening complications from the use of recombinant human Bone Morphogenetic Protein (rhBMP) in cervical spine fusion. Although FDA has approved two rhBMP products for very specific me... Over The Counter Cough and Cold Medications Product labels being modified to state "do not use" in children under 4 years of age. October 2008 Patient Safety News Patient Safety News is a video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Thoratec HeartMate II Left Ventricular Assist System Device correction because the wear and fatigue of the percutaneous lead connecting the blood pump with the system controller may cause serious injury or death. October 28, 2008Recalls and Safety Alerts: CT Scanning May Cause Malfunction of Electronic Medical Devices Recalls and Safety Alerts: CT Scanning May Cause Malfunction of Electronic Medical Devices
FDA is alerting healthcare professionals that the x-rays emitted during CT exams may cause some electronic medical devices to malfunction. These malfunctions are different from those related to MRI scanning, which are caused by strong electrical and... Medtronic Neuromodulation INDURA One-Piece Intrathecal Catheters, Sutureless Pump Connector Revision Kit, Intrathecal Catheter Pump Segment Revision Kit Class I Recall because of potential misconnections of the Medtronic sutureless connector catheters from the catheter port on the pump. Tiotropium (marketed as Spiriva HandiHaler) UPDATE - Preliminary results of the UPLIFT Trial shows no increased risk of stroke with tiotropium bromide. Two recent publications reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Recalls and Safety Alerts: Warning on Tendon Injuries with Fluoroquinolone Antibiotics FDA has asked that a boxed warning be added to the prescribing information for fluoroquinolone antibiotics. The warning will remind healthcare professionals that patients taking these drugs may experience an increased risk of tendinitis and tendon r... October 2008 Patient Safety News Patient Safety News is a video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Preventing Medical Errors: Potentially Fatal Glucose Monitoring Errors with Icodextrin The Institute for Safe Medication Practices (ISMP) is warning again about the possibility of potentially fatal glucose monitoring errors in patients receiving products that contain other sugars. These include oral xylose, parenterals that contain ma... Recalls and Safety Alerts: Avoiding Cardiotoxicity with Mitoxantrone FDA is reemphasizing the importance of monitoring cardiac function in patients treated with mitozantrone, sold as Novantrone and also as a generic. Mitozantrone is used to treat certain patients with prostate cancer, leukemia and multiple sclerosis ... Raptiva (efalizumab) Risk of life-threatening infections associated with Raptiva use. US warns Bayer over aspirins containing supplements - Forbes US warns Bayer over aspirins containing supplements - Forbes
WASHINGTON (Reuters) - Two over-the-counter Bayer (nyse: BAY - news - people ) AG aspirin products that contain dietary supplements have not been proven to work and are being sold illegally, U.S. health regulators warned Tuesday. Claims made about Source: www.forbes.com FDA Sends Warning Letter To Bayer Over Aspirin Claims - Chattershmatter.com The FDA have sent a warning letter to Bayer over two of their over the counter aspirin medications that contain dietary supplements. According to the warning, the medications, Bayer Aspirin with Heart Advantage and Bayer Women’s Low Dose Aspirin Source: www.chattershmatter.com Bayer Aspirin With Supplements Is Illegal, U.S. Warns (Update3) - Bloomberg Oct. 28 (Bloomberg) -- Pills made by Bayer AG that combine aspirin with dietary supplements to fight osteoporosis and high cholesterol are being sold illegally and could harm consumers, U.S. regulators said. The non-prescription products are Bayer Source: www.bloomberg.com FDA issues warning to Bayer - Corpus Christi Caller Bayer is illegally marketing two aspirin products that make unsubstantiated health claims about fighting heart disease and osteoporosis, federal regulators said Tuesday. The Food and Drug Administration issued a warning letter to the German Source: www.caller.com FDA warns Bayer over aspirins with supplements - Guardian Unlimited WASHINGTON, Oct 28 (Reuters) - U.S. health regulators have warned Bayer for selling two over-the-counter aspirin medications that contain dietary supplements without getting approval first, according to documents released on Tuesday. The products Source: www.guardian.co.uk Aspirin Supplements Get Bayer An FDA Warning - HULIQ.com The FDA sent two warning letters to Bayer saying these supplements are illegal when combined with aspirin and the German based company is in violation and “prompt action” needs to be taken. The drugs contain calcium and phytosterols, dietary Source: www.huliq.com FDA warns Bayer over aspirins containing supplements - Reuters WASHINGTON (Reuters) - Two over-the-counter Bayer AG aspirin products that contain dietary supplements have not been proven to work and are being sold illegally, U.S. health regulators warned on Tuesday. Claims made about the products, Bayer Aspirin Source: www.reuters.com UPDATE 2-US warns Bayer over aspirins containing supplements - Reuters WASHINGTON, Oct 28 (Reuters) - Two over-the-counter Bayer AG (BAYG.DE: Quote , Profile , Research , Stock Buzz ) aspirin medications that contain dietary supplements have not been proven to work and mislead consumers, U.S. health regulators warned on Source: www.reuters.com FDA warns Bayer over claims on 2 aspirin products - International Herald Tribune WASHINGTON : Aspirin medicines from Bayer designed to promote healthy hearts and stronger bones are being marketed illegally with unproven health claims, federal regulators said Tuesday. The Food and Drug Administration scolded the company in two Source: www.iht.com Bayer gets FDA warning for illegally marketing two unapproved OTC - RTT News (RTTNews) - The U.S. Food and Drug Administration on Tuesday sent warning letters to Bayer HealthCare, a unit of German drugmaker Bayer AG (BAYRY.PK: News ), concerning what it called two unlawful, over-the-counter aspirin products — Bayer Women's Source: www.rttnews.com Study: Americans spent $12B on diabetes drugs in 2007 - Newsday Study: Americans spent $12B on diabetes drugs in 2007 - Newsday
CHICAGO - Americans with diabetes nearly doubled their spending on drugs for the disease in just six years, with the bill last year climbing to an eye-popping $12.5 billion. Newer, more costly drugs are driving the increase, said researchers, despite Source: www.newsday.com Roche says still discussing Actemra with FDA - Reuters ZURICH, Oct 21 (Reuters) - Roche Holding AG (ROG.VX: Quote , Profile , Research , Stock Buzz ) is still discussing what additional information is required for approval of its Actemra rheumatoid arthritis drug with U.S. regulators, the Swiss company Source: www.reuters.com U.S. FDA extends review of Pfizer osteoporosis drug - San Diego Union-Tribune WASHINGTON – U.S. regulators have extended by three months their review of a proposed osteoporosis drug from Pfizer Inc, a company spokeswoman said Tuesday. The Food and Drug Administration extended the period through January 2009 “to allow the Source: www.signonsandiego.com UPDATE 1-US FDA panel backs Genzyme's mass-produced Myozyme - Reuters SILVER SPRING, Md., Oct 21 (Reuters) - A mass-produced version of Genzyme Corp's (GENZ.O: Quote , Profile , Research , Stock Buzz ) drug to treat the fatal genetic disorder Pompe disease should be approved as long as further studies are required, a U Source: www.reuters.com UPDATE 1-Steris gets US FDA warning on Rhode Island plant - Forbes WASHINGTON, Oct 21 (Reuters) - U.S. regulators have warned Steris Corp about manufacturing problems uncovered during an inspection of a Rhode Island plant, a letter released on Tuesday said. The company failed to maintain adequate procedures to Source: www.forbes.com Genzyme Tells U.S. FDA Panel That Myozyme Is Safe, Effective - Bloomberg Oct. 21 (Bloomberg) -- Genzyme Corp. 's new version of the drug Myozyme is safe and effective to treat a rare genetic condition called Pompe disease, the company told a U.S. panel. Genzyme asked advisers to the Food and Drug Administration today to Source: www.bloomberg.com NFL drug list goes only so far - Minneapolis Star Tribune NFL drug list goes only so far - Minneapolis Star Tribune
A prescription diuretic approved by the Food and Drug Administration in 1983 could become a familiar name to football fans in 2008. It's bumetanide. Several players, including two Vikings, reportedly have tested positive for the drug, which recently Source: www.startribune.com October 27, 2008The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk (October 20) The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk (October 20)
The Hartz Mountain Corporation, Secaucus, NJ is voluntarily recalling one specific lot of Hartz Chicken-Basted Rawhide Chips due to concerns that one or more bags within the lot are potentially contaminated with Salmonella. Hartz is fully cooperating with the US Food and Drug Administration in this voluntary recall. Raptiva (efalizumab) Risk of life-threatening infections associated with Raptiva use. Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System (October 24) Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System (October 24)
Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland The U.S. Food and Drug Administration today approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate. Arnold Foods Company, Inc. Issues Allergy Alert on Undeclared Nuts in Brownberry Whole Grains Bread 100 Percent Whole Wheat (October 8) The product being recalled has a green twist tie with a code date of "Oct 11" printed on the bread bag. No other Arnold brand or Brownberry brand products are affected. Harry and David Issues Nationwide Allergy Alert on Undeclared Pecans in Harry and David Moose Munch Confection, Milk Chocolate Gingerbread (October 22) Harry and David, of Medford, Oregon, is voluntarily recalling approximately 400 1 lb. 4 oz. boxes labeled Harry and David Moose Munch Confection, Milk Chocolate Gingerbread because the package may contain a different Moose Munch product which contains pecans not declared on the ingredient statement. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume this product. FDA Approves Lung Valve to Control Some Air Leaks after Surgery The U.S. Food and Drug Administration today approved an implantable and removable valve system designed to control some air leaks in the lungs that persist after certain kinds of lung surgery. HUA XIA Food Trade USA, Inc. Recalls YILI Brand Sour Milk Drink and YILI Brand Pure Milk Drink, Because of Possible Health Risk (October 10) HUA XIA Food Trade USA, Inc. of Flushing, NY, is recalling YILI Brand Sour Milk Drink packaged in 250ml flexible paperboard boxes (all codes and all lots are affected) and YILI Brand Pure Milk Drink packaged in 250ml flexible paperboard boxes (all codes and all lots are affected) because it may be contaminated with melamine. Barry Callebaut USA LLC Issues Allergen Alert on Undeclared Milk Protein in Kroger Value Semi Sweet Chocolate Chips (October 10) Barry Callebaut USA LLC is conducting a voluntary recall on its product sold by Kroger Stores under the brand "Kroger Value Semi Sweet Chocolate Chips", 12 oz., UPC Code is 11110–86603 and "sell by" date May 30, 2010, as the product may contain undeclared milk protein. The "sell by" date is found printed in black on the end of the bag. People with allergies or severe sensitivity to milk protein may be at risk of serious or life-threatening allergic reaction if they consume this product. FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials. Nonna's Real Italiana Cuccine Issues an Allergy Alert on Undeclared Milk, Soy, and Wheat in Stuffed Artichokes (October 22) This product is distributed through retailers in the Greater New Orleans area including the Northshore from October 8, 2008 to October 17, 2008. The product is individually wrapped in clear plastic wrap bearing the label: "STUFFED ARTICHOKE, Net Wt. 15 oz., NONNA'S REAL ITALIANA CUCCINE". Bayer HealthCare's New Sterile Fill Facility Receives EMEA, FDA - Earthtimes Bayer HealthCare's New Sterile Fill Facility Receives EMEA, FDA - Earthtimes
BERKELEY, Calif. - (Business Wire) The European Medicines Agency (EMEA) has granted license approval to Bayer HealthCare LLC (Bayer) for its new sterile filling facility (SFF) on its Berkeley, Calif. campus. The approval closely follows authorization Source: www.earthtimes.org Study Suggests Expanded Prevnar Vaccine Will Be Effective - CNN Money WASHINGTON -(Dow Jones)- A new, expanded version of Wyeth's (WYE) Prevnar vaccine may be as effective as the current version, according to the first look at advanced clinical studies of the vaccine released Monday. Prevnar, given to infants and Source: money.cnn.com Dune Medical Launches US FDA Cleared Clinical Trial for Use of - PR Inside - Dune Medical Devices, Ltd. today announced the launch of a pivotal clinical trial of the MarginProbe(TM) intraoperative, real-time, positive margin detection system, following U.S. Food and Drug Administration (FDA) investigational device exemption Source: www.pr-inside.com Rohm and Haas to present Bio-Pruf(TM) Solutions at Technical Seminar - MSN MoneyCentral Mold, mildew, algae and bacteria can leave a mark on painted surfaces in the bathroom or the kitchen. Advanced biocide technology from Rohm and Haas ROH can protect many surfaces from the effects of microorganisms. Rohm and Haas, the world ’ s Source: news.moneycentral.msn.com Dextroamphetamine Sulfate 5mg Tablets Dextroamphetamine Sulfate 5mg Tablets
Drug recall due to the potential for oversized tablets that may be associated with an increased risk of adverse effects. Epoetin alfa Preliminary safety findings from a German clinical trial showed more deaths in patients given epoetin-alpha versus placebo. FDA Approves Updated Labeling for Psoriasis Drug Raptiva FDA Approves Updated Labeling for Psoriasis Drug Raptiva
The U.S. Food and Drug Administration announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS. FDA Requires Stronger Fungal Infection Warning for TNF Blockers FDA has told the makers of drugs known as "tumor necrosis factor alpha blockers" (TNF-alpha blockers) to strengthen existing labeling. Safety Concerns and Labeling Changes for Psoriasis Drug Raptiva FDA has received reports of serious infections leading to hospitalizations and deaths in people who use Raptiva. Irradiation: A Safe Measure for Safer Iceberg Lettuce and Spinach In the fight against foodborne illness, FDA is permitting fresh iceberg lettuce and fresh spinach to be irradiated at safe doses. Is It Really FDA Approved? Some marketers say their products are "FDA approved", but how can you know for sure? FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change such as this one. Therefore, some medicines will have the new recommendation "do not use" for children under 4 years of age, while others will instruct that they not be used for children under 2 years of age. If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, FDA recommends that they should adhere to the dosage instructions and warnings on the label that accompanies the medication. They should not, under any circumstances, give adult medications to children. If parents or caregivers have questions or are just not sure about how to use a product, they should consult with their doctor or pharmacist. FDA Licenses for Marketing New Therapy for Rare Genetic Disease The U.S. Food and Drug Administration today licensed for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. HAE affects about 6,000 to 10,000 individuals in the United States. FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials. AMAG gets FDA request for more data on anemia drug - CNN Money AMAG gets FDA request for more data on anemia drug - CNN Money
NEW YORK (Associated Press) - Biotechnology company AMAG Pharmaceuticals Inc. said Monday the Food and Drug Administration wants more information on a prospective anemia drug before considering it for approval. In December, AMAG asked the FDA to Source: money.cnn.com FDA Defers Final Action on milnacipran New Drug Application - MSN MoneyCentral NEW YORK and SAN DIEGO , Oct. 20 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. FRX and Cypress Bioscience, Inc. CYPB (the "Companies") today announced that the U.S. Food and Drug Administration (FDA) has advised the Companies that it was not Source: news.moneycentral.msn.com FDA rejects Abbott's extended-release Vicodin - Chicago Tribune The U.S. Food and Drug Administration did not approve Abbott Laboratories ' extended-release formulation of the painkiller Vicodin, the North Chicago -based drug giant confirmed Monday afternoon. The FDA's decision to issue a "complete response Source: www.chicagotribune.com Prime Meridian - Baltimore Sun As governments, both federal and municipal, have geared up post Sept. 11, many have turned to Columbia's Meridian Medical Technologies for their popular auto-injectors. James H. Miller, Meridian's chairman, president and CEO, recently discussed the Source: www.baltimoresun.com Ex-ImClone CEO pleads guilty - Baltimore Sun NEW YORK - Samuel D. Waksal, the jet-setting scientist and entrepreneur who founded ImClone Systems Inc. , pleaded guilty Tuesday to bank and securities fraud in a mushrooming scandal that also threatens his friend and investor, Martha Stewart Source: www.baltimoresun.com FDA clearance on treatments doesn't mean they work - Seattle Times After a surgeon removed a cancerous lump from Karen Medlock's breast in November, he recommended radiation, a routine next step meant to keep cancer from recurring. But he did not send her for the kind of radiation most women have received for Source: seattletimes.nwsource.com FDA opening China office to inspect imports - Atlanta Journal Constitution WASHINGTON — The Food and Drug Administration will establish its first office in China before the end of the year as part of a broader plan to assure the safety of imports from the developing world. FDA Commissioner Andrew von Eschenbach on Source: www.ajc.com Cancer therapy raises questions about FDA's reviews - Boston Globe After a surgeon removed a cancerous lump from Karen Medlock's breast in November, he recommended radiation, a routine next step meant to keep cancer from recurring. But he did not send her for the kind of radiation most women have received for Source: www.boston.com In Drug Case, Justices to Weigh Right to Sue - Wall Street Journal For nearly a century, Americans have been able to sue drug companies for deaths or injuries caused by medicines. Now the pharmaceutical industry and other big businesses are hoping the Supreme Court will sharply curb that right. Stephen Breyer In a Source: online.wsj.com EDITORIAL: Conflict taints FDA safety review - New Haven Register No comments posted. Concerns mount about chemical used in plastic for baby and drinking bottles. The U.S. Food and Drug Administration said in August that bisphenol A, or BPA, a chemical used in hard plastics such as water bottles and coatings of Source: www.nhregister.com October 26, 2008AMAG gets FDA request for more data on anemia drug - CNN Money AMAG gets FDA request for more data on anemia drug - CNN Money
NEW YORK (Associated Press) - Biotechnology company AMAG Pharmaceuticals Inc. said Monday the Food and Drug Administration wants more information on a prospective anemia drug before considering it for approval. In December, AMAG asked the FDA to Source: money.cnn.com Forest, Cypress face delay in FDA drug review - MSN MoneyCentral NEW YORK (AP) - Forest Laboratories Inc. and Cypress Bioscience Inc. said Monday the Food and Drug Administration will delay reviewing their application for a prospective fibromylagia drug, but has not given a reason or timeline. The companies said Source: news.moneycentral.msn.com In Drug Case, Justices to Weigh Right to Sue - Wall Street Journal For nearly a century, Americans have been able to sue drug companies for deaths or injuries caused by medicines. Now the pharmaceutical industry and other big businesses are hoping the Supreme Court will sharply curb that right. Stephen Breyer In a Source: online.wsj.com BRIEF-Cardium gets FDA nod for endovascular system - Forbes Copyright Thomson Financial News Limited 2007. All rights reserved. The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Source: www.forbes.com Competitive Technologies Provides Additional Information for FDA 510(k - MSN MoneyCentral FAIRFIELD, Conn., Oct. 20, 2008 (GLOBE NEWSWIRE) -- Competitive Technologies, Inc. (NYSE Alternext US:CTT) (AMEX:CTT) announced today that it has provided additional information to the FDA regarding CTT's pain management therapy device. CTT is Source: news.moneycentral.msn.com UPDATE 1-Forest, Cypress fibromyalgia drug delayed at FDA - Reuters BOSTON, Oct. 20 (Reuters) - Forest Laboratories Inc (FRX.N: Quote , Profile , Research , Stock Buzz ) and Cypress Bioscience Inc (CYPB.O: Quote , Profile , Research , Stock Buzz ) said on Monday the U.S. Food and Drug Administration was not able to Source: www.reuters.com Genzyme Hits an FDA Snag - Wall Street Journal Genzyme Hits an FDA Snag - Wall Street Journal
The Food and Drug Administration questioned Friday whether a study submitted by Genzyme Corp. is strong enough to merit expanded approval of a drug to treat a rare illness known as Pompe disease. The drug, Myozyme, was first approved in 2006 to treat Source: online.wsj.com BRIEF-Teva gets FDA nod for fentanyl transdermal system - Forbes Copyright Thomson Financial News Limited 2007. All rights reserved. The copying, republication or redistribution of Thomson Financial News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Source: www.forbes.com FDA wants more data on AMAG anemia drug - Boston Globe Biotechnology company AMAG Pharmaceuticals Inc. of Cambridge said today that the Food and Drug Administration wants more information on a prospective anemia drug before considering it for approval. In December, AMAG asked the FDA to approve Source: www.boston.com UPDATE 1-Forest, Cypress fibromyalgia drug delayed at FDA - Reuters BOSTON, Oct. 20 (Reuters) - Forest Laboratories Inc (FRX.N: Quote , Profile , Research , Stock Buzz ) and Cypress Bioscience Inc (CYPB.O: Quote , Profile , Research , Stock Buzz ) said on Monday the U.S. Food and Drug Administration was not able to Source: www.reuters.com Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System (October 24) Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System (October 24)
Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. Dextroamphetamine Sulfate 5mg Tablets Drug recall due to the potential for oversized tablets that may be associated with an increased risk of adverse effects. FDA Detects Melamine Contamination in Flavored Drink The U.S. Food and Drug Administration (FDA) has increased inspections and product testing efforts in response to the melamine contamination problem which originated in Chinese dairy products. As a result of the FDA's on-going testing program, the agency has detected melamine contamination in Blue Cat Flavor Drinks. The distributor of the product, Tristar Food Wholesale Co. Inc., initiated a recall of several flavors of Blue Cat Flavor Drink, based on the FDA’s findings. The FDA advises the public not to consume this product and recommends that retailers and food service operators remove the product from sale or service. Harry and David Issues Nationwide Allergy Alert on Undeclared Pecans in Harry and David Moose Munch Confection, Milk Chocolate Gingerbread (October 22) Harry and David, of Medford, Oregon, is voluntarily recalling approximately 400 1 lb. 4 oz. boxes labeled Harry and David Moose Munch Confection, Milk Chocolate Gingerbread because the package may contain a different Moose Munch product which contains pecans not declared on the ingredient statement. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume this product. October 2008 Patient Safety News Patient Safety News is a video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients. Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection See Web site for additional information Consumer Alert: Possible Botulism Contamination in Frozen Salted Croaker (October 6) Consumer Alert: Possible Botulism Contamination in Frozen Salted Croaker (October 6)
New York State Agriculture Commissioner alerted consumers not to eat Frozen Salted Croaker distributed by YS Trading Corp, Long Island City, New York because the product was uneviscerated. The Frozen Salted Croaker was sold in Hicksville, New York, Flushing, New York, and New Jersey in un-coded, unlabeled plastic bags. Is It Really FDA Approved? Some marketers say their products are "FDA approved", but how can you know for sure? Lotte USA, Inc. Initiates Nationwide Recall of Koala's March Creme filled Cookies Lotte USA, Inc., Battle Creek, MI initiated a recall of all Koalas' March Cookies on September 29, 2008 because they were produced in China and they may be contaminated with melamine. The products are packaged in a plastic overwrap. Safety and Food Packaging FDA monitors all packaging that comes into contact with food. Here's an overview of how FDA conducts safety reviews of food contact substances. Using Over-the-Counter Cough and Cold Products in Children FDA supports the voluntary actions of drug manufacturers to better inform consumers about the safe and effective use of over-the-counter cough and cold medicines in children. McCormick and Company Has Recalled McCormick Enchilada Sauce Mix Due To Unlabeled Milk Ingredients (September 30) The McCormick Enchilada Sauce Mix was distributed to grocery stores nationally beginning on September 17, 2008. The product comes in 1.5 oz. pouches with an expiration date of "best by" AUG2910CH. The date is found printed in black on the back, bottom left of the pouch. The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk (October 20) The Hartz Mountain Corporation, Secaucus, NJ is voluntarily recalling one specific lot of Hartz Chicken-Basted Rawhide Chips due to concerns that one or more bags within the lot are potentially contaminated with Salmonella. Hartz is fully cooperating with the US Food and Drug Administration in this voluntary recall. Russell Stover Candies, Inc. Issues Hazelnut Allergy Alert for the 2 7/8 Oz Size Of Private Reserve Assorted Chocolates (October 9) The recalled product was distributed in the following states and cities: Texas, California, Louisiana, North Carolina, South Carolina, Virginia, Tennessee; Southaven, Mississippi; Billings, Montana; Sparks, Nevada; and Madison Heights, Michigan. An investigation determined 29 boxes of this candy may have been purchased by consumers, and up to another 188 boxes may have reached retail store locations. All the retail stores have been contacted to have the suspected product removed from the shelves. In-Body Pediatric Devices Pose Unique Challenges Implantable pediatric medical devices are exciting examples of cutting-edge medical technology. But they require special considerations on the part of parents, health professionals, and scientists who design devices. |
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