July 19, 2008Safety issues fail to halt drug imports - Newark Star-Ledger Safety issues fail to halt drug imports - Newark Star-Ledger
For 2 1/2 years, the Food and Drug Administration collected evidence that Ranbaxy Laboratories, India's largest generic drugmaker, may have lied about the quality of medicines and chemicals it sent to the U.S. Regulators inspected Ranbaxy plants in Source: www.nj.com HEALTH CARE: Rx push is on - Tonawanda News The county Legislature is being asked to give a renewed push to prescription drug discount cards that are available to every Niagara County resident. The Niagara Rx program has been in place for about four years, but it’s little used. According to Source: www.tonawanda-news.com China denies Olympic ban on drug sales - Reuters UK BEIJING (Reuters) - China denied on Friday that pharmacies had banned the sale of everyday products such as cold medication and rash cream to prevent accidental doping during the Olympics, and sought to assure that drugs would meet standards. Yan Source: uk.reuters.com Family Sues Company for Experimental Muscular Dystrophy Drug - FOX News A Minnesota family is trying to force a New Jersey drug company to give their son an experimental drug for a fatal form of muscular dystrophy, saying he'll die without it. The boy's mother, Cheri Gunvalson, who helped persuade Congress to Source: www.foxnews.com Tomato growers wonder if US crop can overcome bad rap from salmonella - Baltimore Sun RICHMOND, Va. (AP) _ The 6,000 acres of tomatoes grown on Virginia's sea-swept Eastern Shore were never implicated in the national salmonella outbreak — they were still on the vine weeks after people starting getting sick. Still, that hasn't made Source: www.baltimoresun.com Celera gets FDA approval for diagnostic software - CNBC ALAMEDA, Calif. - Molecular diagnostics company Celera Corp. said Friday the Food and Drug Administration approved new system software used for HIV monitoring and treatment. The new software for the ViroSeq HIV-1 Genotyping system is designed to Source: www.cnbc.com Should You Look Into Your Genes? - Washington Post Jeffrey Gulcher had no reason to think much about prostate cancer. He was just 48, and the disease typically strikes later in life. Even the most cautious medical groups agree that most men need not begin annual prostate screenings until age 50. But Source: www.washingtonpost.com Anti-smoking drug study investigated - The Washington Times Officials with the Department of Veterans Affairs are preparing to determine who was at fault for failing to quickly notify participants in a smoking-cessation study about the potentially dangerous side effects of a drug they were prescribed and Source: washingtontimes.com Drug taken to stop smoking is linked to traffic mishaps - Fort Lauderdale Sun-Sentinel WASHINGTON - Daniel Williams decided he'd listen to his girlfriend and his 8-year-old son and finally quit smoking, with the help of a new prescription drug called Chantix. He started taking the medication, and a couple of nights later, as he was Source: www.sun-sentinel.com Family sues for trial muscular dystrophy drug - CNBC WASHINGTON - A Minnesota family is trying to force a New Jersey drug company to give their son an experimental drug for a fatal form of muscular dystrophy, saying he'll die without it. The boy's mother, Cheri Gunvalson, who helped persuade Congress Source: www.cnbc.com May 2008 Monthly Safety Labeling May 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. April 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Preventing Medical Errors: Preventing Fatal Overdoses with Cerebyx The Institute for Safe Medication Practices (ISMP) and FDA are warning healthcare professionals that potentially fatal dosing errors continue to occur with the anti-epileptic drug Cerebyx (fosphenytoin), despite clarifications in the drug's labeling ... Radiology and Children: Extra Care Required Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. Beware of Online Cancer Fraud FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice. Heartworm Prevention in Your Pet A variety of FDA-approved heartworm prevention products are available to protect your pet from this potentially deadly infection, including ProHeart 6 injection for dogs under a restricted distribution program. FDA 101: Biological Products Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies. FDA Approves Diaphragm-Pacing Device FDA Approves Diaphragm-Pacing Device
The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs The U.S. Food and Drug Administration today exercised its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA) to require manufacturers of "conventional" antipsychotic drugs to make safety-related changes to prescribing information, or labeling, to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. FDA 101: Advisory Committees FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees. Radiology and Children: Extra Care Required Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. FDA Lifts Warning About Eating Certain Types of Tomatoes After a lengthy investigation, the FDA has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency is removing its June 7 warning against eating certain types of red raw tomatoes. Beware of Bug Bites and Stings Ticks, mosquitoes, and bees--here are tips for preventing and treating bug bites and stings. FDA declares it's OK to eat tomatoes again - Seattle Post Intelligencer FDA declares it's OK to eat tomatoes again - Seattle Post Intelligencer
In this June 10, 2008 file photo, showing Canadian Hot House Tomatoes at a produce seller at the Reading Terminal Market in Philadelphia. The FDA declares it's OK to eat tomatoes again, Thursday, July 17, 2008, lifting its salmonella warning as Source: seattlepi.nwsource.com FDA lifts warning on tomatoes - CNN (CNN) -- Tomatoes are again safe to eat, the Food and Drug Administration said Thursday, weeks after the food was blamed as a source of a salmonella outbreak in the United States and Canada. The source of the outbreak of salmonella still isn't known Source: www.cnn.com Tomatoes OK to eat, FDA says, but avoid hot peppers - Houston Chronicle WASHINGTON — The U.S. government has declared it's OK to eat tomatoes again, lifting its salmonella warning amid signs that the outbreak — while not over — may finally be slowing. Officials reiterated earlier warnings that the people most at Source: www.chron.com FDA Says It's Safe to Eat Tomatoes - Forbes THURSDAY, July 17 (HealthDay News) -- U.S. health officials on Thursday dropped their warning against eating fresh tomatoes, as the toll in the ongoing salmonella outbreak reached 1,220 confirmed cases, with at least 242 people hospitalized. "As of Source: www.forbes.com FDA gives all-clear on tomatoes, not peppers - Chicago Tribune WASHINGTON — The Food and Drug Administration declared on Thursday that it is again safe to eat all tomatoes now on sale in the U.S., canceling its warning in June that some tomatoes were the cause of a still-unsolved outbreak of salmonella Source: www.chicagotribune.com FDA Clears Suspect Tomatoes - ABC News Consumers got the go-ahead this afternoon to eat tomatoes again, following months of concern that the produce was linked to more than 1,000 cases of salmonella. Tomatoes are shown at Eastern Market in Detroit, Wednesday, July 16, 2008, in Detroit Source: www.abcnews.go.com FDA: OK to eat tomatoes again - USA Today Tomatoes are offered for sale at Eastern Market in Washington, D.C. WASHINGTON (AP) — The U.S. government has declared it's OK to eat tomatoes again, lifting its salmonella warning amid signs that the outbreak — while not over — may finally be Source: www.usatoday.com FDA declares it's OK to eat tomatoes again - Kansas City Star In this June 10, 2008 file photo, a plum tomato is displayed in Philadelphia. The U.S. government on Thursday, July 17, 2008 declared it's OK to eat tomatoes again, lifting its salmonella warning amid signs that the outbreak _ while not over _ may Source: www.kansascity.com FDA Grants Clearance for Celera's ViroSeq(R) HIV-1 Genotyping System - PR Inside -- The addition in the resistance algorithm of two new drugs, INTELENCE(TM) (etravirine) and PREZISTA(TM) (darunavir) from Tibotec Therapeutics, a division of Ortho Biotech Products, L.P.; -- An update of the resistance algorithm for all currently Source: www.pr-inside.com FDA: All Tomatoes Cleared of Salmonella Risk - Washington Post FDA: All Tomatoes Cleared of Salmonella Risk - Washington Post
All types of fresh tomatoes are safe to eat, federal health officials said yesterday, lifting a six-week-old warning that led restaurants to pull them and triggered tens of millions of dollars in losses for the tomato industry. Officials with the Source: www.washingtonpost.com Bush offers to talk on Iraq timetable - Detroit News WASHINGTON -- President Bush has agreed to set a "general time horizon" for deeper U.S. troop cuts in Iraq, the White House said Friday, a dramatic shift from his once-ironclad unwillingness to talk about any kind of deadlines or timetables. The Source: www.detnews.com FDA comes under Congress scanner over Ranbaxy issue - Times of India NEW YORK: The US drug regulator FDA, which has charged Ranbaxy of selling unsafe medicines in the country, has come under the parliamentary scanner and will be probed for its conduct in approving the Indian pharma major's products and other potential Source: timesofindia.indiatimes.com FDA gives all-clear on tomatoes, not peppers - Chicago Tribune WASHINGTON — The Food and Drug Administration declared on Thursday that it is again safe to eat all tomatoes now on sale in the U.S., canceling its warning in June that some tomatoes were the cause of a still-unsolved outbreak of salmonella Source: www.chicagotribune.com FDA decides it's safe to eat tomatoes - Boston Globe WASHINGTON - It's OK to eat all kinds of tomatoes again, the US government declared yesterday - lifting its salmonella warning on the summer favorites amid signs the record outbreak, while not over, may finally be slowing. Hot peppers still get a Source: www.boston.com Stryker stock declines after warnings - Detroit Free Press Stryker stock declines after warnings - Detroit Free Press
Shares fell $2.96, or 4.3%, to close at $65.45 on the New York Stock Exchange. Stryker stock has lost 12.4% this year. The Food and Drug Administration has issued three warning letters to Stryker alleging manufacturing deficiencies at three plants. Source: www.freep.com Family sues co. for muscular dystrophy drug - NWITimes.com WASHINGTON - A Minnesota family is trying to force a New Jersey drug company to give their son an experimental drug for a fatal form of muscular dystrophy, saying he'll die without it. The boy's mother, Cheri Gunvalson, who helped persuade Congress Source: nwitimes.com Tomato scare squishes producers - United Press International SALINAS, Calif., July 19 (UPI) -- A recent salmonella outbreak has hit California tomato growers hard, with sales plummeting, experts say. Growers say by the time the U.S. Food and Drug Administration cleared tomatoes Thursday in its investigation of Source: www.upi.com Critics question FDA, U.S. Customs handling of Ranbaxy case - Newark Star-Ledger For two and a half years, the Food and Drug Administration collected evidence that Ranbaxy Laboratories, India's largest generic drugmaker, may have lied about the quality of medicines and chemicals it sent to the U.S. Regulators inspected Ranbaxy Source: www.nj.com Medivation drug improves Alzheimer's symptoms - CNN Money NEW YORK (Associated Press) - Biotechnology company Medivation Inc. said Thursday that Alzheimer's disease patient's taking the experimental drug Dimebon showed a significant improvement after six months and continued to benefit from the drug up to a Source: money.cnn.com UPDATE 2-FDA approval for Labopharm's Tramadol seen by Jan - Reuters UPDATE 2-FDA approval for Labopharm's Tramadol seen by Jan - Reuters
TORONTO, July 17 (Reuters) - Labopharm Inc (DDS.TO: Quote , Profile , Research , Stock Buzz ) inched closer to U.S. approval of the once-daily version of its Tramadol pain treatment on Thursday, after the Food and Drug Administration accepted the Source: www.reuters.com Critics question FDA, U.S. Customs handling of Ranbaxy case - Newark Star-Ledger For two and a half years, the Food and Drug Administration collected evidence that Ranbaxy Laboratories, India's largest generic drugmaker, may have lied about the quality of medicines and chemicals it sent to the U.S. Regulators inspected Ranbaxy Source: www.nj.com FDA Clears Suspect Tomatoes - ABC News Consumers got the go-ahead this afternoon to eat tomatoes again, following months of concern that the produce was linked to more than 1,000 cases of salmonella. Tomatoes are shown at Eastern Market in Detroit, Wednesday, July 16, 2008, in Detroit Source: www.abcnews.go.com Critics question FDA, U.S. Customs handling of Ranbaxy case - Newark Star-Ledger Critics question FDA, U.S. Customs handling of Ranbaxy case - Newark Star-Ledger
For two and a half years, the Food and Drug Administration collected evidence that Ranbaxy Laboratories, India's largest generic drugmaker, may have lied about the quality of medicines and chemicals it sent to the U.S. Regulators inspected Ranbaxy Source: www.nj.com UPDATE 1-FDA to rule on Labopharm's Tramadol by January - Reuters UPDATE 1-FDA to rule on Labopharm's Tramadol by January - Reuters
TORONTO, July 17 (Reuters) - The U.S. Food and Drug Administration has accepted the analysis Canadian drug company Labopharm Inc (DDS.TO: Quote , Profile , Research , Stock Buzz ) has provided on its once-daily version of the pain treatment Tramadol Source: www.reuters.com Drug Shortage: Fentanyl transdermal patch Drug Shortage: Fentanyl transdermal patch
Availability information updated. Preventing Medical Errors: Preventing Fatal Overdoses with Cerebyx The Institute for Safe Medication Practices (ISMP) and FDA are warning healthcare professionals that potentially fatal dosing errors continue to occur with the anti-epileptic drug Cerebyx (fosphenytoin), despite clarifications in the drug's labeling ... Avastin (bevacizumab) Reports of microangiopathic hemolytic anemia in patients treated with this unapproved combination. New Medical Products: New Skin Graft Adhesive Approved FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi... Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP) Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP. Dear Healthcare Professional Letter is available for more information. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Important Information about Albuterol Metered Dose Inhalers (MDIs) After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information) Drug Shortage: Digitek (digoxin tablets, USP) Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalled of all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP). Other manufacturers of digoxin tablets are available and listed on the Drug Shortage website. Myfortic (mycophenolate acid) Myfortic (mycophenolate acid)
Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic. United States and China Outline Progress on Agreement on Food and Feed Safety (HHS Release) U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People�s Republic of China. The document outlines steps taken by both nations in implementing the 2007 Memorandum of Agreement (MOA) on food and feed safety. Giant Food Alerts Customers to Voluntary Recall of Giant Brand Garlic Bread and Garlic Spread (June 27) Giant Food has announced a voluntary recall of Giant brand garlic bread and garlic spread products sold in its Bakeshop as the items contain milk products which are not declared on the labels. Giant removed from its shelves all 16 ounce packages of Giant brand garlic bread and all 16 ounce packages of Giant brand garlic spread products. FDA Lifts Warning About Eating Certain Types of Tomatoes After a lengthy investigation, the FDA has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency is removing its June 7 warning against eating certain types of red raw tomatoes. Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). May 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. FDA Approves First Generic Risperidone to Treat Psychiatric Conditions The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions. FDA Food Protection Plan Shows Significant Progress The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007. FDA declares it's OK to eat tomatoes again - Boston Globe FDA declares it's OK to eat tomatoes again - Boston Globe
WASHINGTON— It's OK to eat all kinds of tomatoes again, the U.S. government declared Thursday -- lifting its salmonella warning on the summer favorites amid signs that the record outbreak, while not over, may finally be slowing. Hot peppers still Source: www.boston.com FDA Clears Suspect Tomatoes - ABC News Consumers got the go-ahead this afternoon to eat tomatoes again, following months of concern that the produce was linked to more than 1,000 cases of salmonella. Tomatoes are shown at Eastern Market in Detroit, Wednesday, July 16, 2008, in Detroit Source: www.abcnews.go.com FDA lifts warning on tomatoes - CNN (CNN) -- Tomatoes are again safe to eat, the Food and Drug Administration said Thursday, weeks after the food was blamed as a source of a salmonella outbreak in the United States and Canada. The source of the outbreak of salmonella still isn't known Source: www.cnn.com UPDATE 1-FDA to rule on Labopharm's Tramadol by January - Reuters TORONTO, July 17 (Reuters) - The U.S. Food and Drug Administration has accepted the analysis Canadian drug company Labopharm Inc (DDS.TO: Quote , Profile , Research , Stock Buzz ) has provided on its once-daily version of the pain treatment Tramadol Source: www.reuters.com BSD Medical Responds to FDA On Its BSD-2000 PMA Application - MSN MoneyCentral SALT LAKE CITY, July 17, 2008 (PRIME NEWSWIRE) -- BSD Medical Corporation (Nasdaq:BSDM) today announced that a formal response has been hand delivered to the Food and Drug Administration (FDA) pertaining to the BSD-2000 Hyperthermia System submission Source: news.moneycentral.msn.com Salmonella scare hit state growers hard - San Francisco Gate By the time the Food and Drug Administration cleared tomatoes Thursday in its investigation of a salmonella outbreak, California's tomato sales had plummeted more than 40 percent. "It's a government-made disaster," said Melanie Horwath, office Source: www.sfgate.com FDA Sends Letter To Wyeth Over Violative Benefix Flashcard - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration sent a letter to Wyeth (WYE), saying a promotional "flashcard" for the hemophilia drug Benefix is misleading because it suggests Benefix is safer than another drug, CSL's ( CSL.AU Source: money.cnn.com FDA Revises Process for Responding to Drug Applications FDA Revises Process for Responding to Drug Applications
The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. FDA Food Protection Plan Shows Significant Progress The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007. Stryker stock declines after warnings - Detroit Free Press Stryker stock declines after warnings - Detroit Free Press
Shares fell $2.96, or 4.3%, to close at $65.45 on the New York Stock Exchange. Stryker stock has lost 12.4% this year. The Food and Drug Administration has issued three warning letters to Stryker alleging manufacturing deficiencies at three plants. Source: www.freep.com Family sues drug company to get access to muscular dystrophy drug - Newsday WASHINGTON (AP) _ A Minnesota family is trying to force a New Jersey drug company to give their son an experimental drug for a fatal form of muscular dystrophy, saying he'll die without it. The boy's mother, Cheri Gunvalson, who helped persuade Source: www.newsday.com OXiGENE Announces Clinical Trials Data to be Presented At the 7th - MSN MoneyCentral ZYBRESTAT (fosbretabulin) is currently being evaluated in a pivotal registration study as a potential treatment for anaplastic thyroid cancer (ATC) under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA). Phase Source: news.moneycentral.msn.com Traveler's diarrhea drug said to work - San Diego Union-Tribune A San Diego company developing an antibiotic for traveler's diarrhea said results from a late-stage clinical trial show that its product is faster and works on a broader range of gut-wrenching bacteria than those already on the market. The trial Source: www.signonsandiego.com FDA Sends Letter To Wyeth Over Violative Benefix Flashcard - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration sent a letter to Wyeth (WYE), saying a promotional "flashcard" for the hemophilia drug Benefix is misleading because it suggests Benefix is safer than another drug, CSL's ( CSL.AU Source: money.cnn.com F.D.A. Lifts Tomato Warning - The Ledger The Food and Drug Administration revoked its warning against eating certain kinds of raw tomatoes Thursday, even though officials said they had yet to pinpoint the source of the nation’s largest foodborne outbreak in the last decade. Meanwhile, the Source: www.theledger.com Globalism and poison food - WorldNetDaily I mean, who would have imagined that opening up America's food sources to China and Mexico would mean consumers would be eating fish contaminated with human waste and tomatoes and avocadoes tainted with salmonella? Presumably our distinguished Source: www.worldnetdaily.com It’s Now Official: Tomatoes Are Salmonella-Free - Eflux Media On Thursday, federal health officials finally lifted the 40 day-old warning with regard to tomatoes, that has caused industry losses of about $250 million. Up to this point, investigators have analyzed more than 1,700 samples (soil, water and Source: www.efluxmedia.com Food bank, others aim to feed kids - Coloradoan With the number of children living in poverty on the rise in Larimer County, the Summer Food Service Program is feeding record numbers of children at the Fort Collins Boys & Girls Club. But the Food Bank for Larimer County and its partners want to Source: www.coloradoan.com Biocon to market new breast cancer drug in India - New Kerala Biocon to market new breast cancer drug in India - New Kerala
Bangalore, July 18: Biotechnology major Biocon Ltd will market Abraxane drug of the US-based Abraxis BioScience in India for treating breast cancer, a top company official said here Friday. To be priced at about $400 (Rs.17,200) per 100mg vial in Source: www.newkerala.com Stryker stock declines after warnings - Detroit Free Press Shares fell $2.96, or 4.3%, to close at $65.45 on the New York Stock Exchange. Stryker stock has lost 12.4% this year. The Food and Drug Administration has issued three warning letters to Stryker alleging manufacturing deficiencies at three plants. Source: www.freep.com China drug regulator: Warning not a ban of drug sales - Xinhua News Agency BEIJING, July 17 (Xinhua) -- China's drug watchdog said Thursday it had not banned drug retailers from selling medicines containing stimulants during Olympics. A spokesman with the State Food and Drug Administration (SFDA) said drugstores should not Source: news.xinhuanet.com FDA Sends Letter To Wyeth Over Violative Benefix Flashcard - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration sent a letter to Wyeth (WYE), saying a promotional "flashcard" for the hemophilia drug Benefix is misleading because it suggests Benefix is safer than another drug, CSL's ( CSL.AU Source: money.cnn.com A sour taste or sweet embrace? - Times Union Mike Ryan, vice president of W.F. Ryan Produce in Colonie, doesn't want to be one to say "I told you so" when it came to the tomato scare, but he did. When the Food and Drug Administration warned consumers on June 7 that certain tomato varieties may Source: timesunion.com Family Sues to Get Experimental Drug - AOL WASHINGTON (July 18) - A Minnesota family is trying to force a New Jersey drug company to give their son an experimental drug for a fatal form of muscular dystrophy, saying he'll die without it. The boy's mother, Cheri Gunvalson, who helped persuade Source: news.aol.com Two US Congress members question Ranbaxy - MSN India New Delhi: Two United States (US) Congress members have expressed doubts over the quality of inspections that are conducted by the US Food and Drugs Administration (FDA) on Indian drug manufacturing facilities before giving them the nod to market Source: news.in.msn.com FDA: OK to eat tomatoes again - USA Today FDA: OK to eat tomatoes again - USA Today
Tomatoes are offered for sale at Eastern Market in Washington, D.C. WASHINGTON (AP) — The U.S. government has declared it's OK to eat tomatoes again, lifting its salmonella warning amid signs that the outbreak — while not over — may finally be Source: www.usatoday.com FDA declares it's OK to eat tomatoes again - NWITimes.com WASHINGTON - It's OK to eat all kinds of tomatoes again, the U.S. government declared Thursday _ lifting its salmonella warning on the summer favorites amid signs that the record outbreak, while not over, may finally be slowing. Hot peppers still get Source: nwitimes.com FDA: It’s OK to eat tomatoes again - MSNBC The U.S. government has declared it’s OK to eat tomatoes again, lifting its salmonella warning amid signs that the outbreak — while not over — may finally be slowing. Officials reiterated earlier warnings that the people most at risk of Source: www.msnbc.msn.com FDA lifts warning on tomatoes - CNN (CNN) -- Tomatoes are again safe to eat, the Food and Drug Administration said Thursday, weeks after the food was blamed as a source of a salmonella outbreak in the United States and Canada. The source of the outbreak of salmonella still isn't known Source: www.cnn.com McCain gets uneasy over birth control - Miami Herald C onfronted with the question of whether insurance companies that cover Viagra should also pay for contraception, Republican John McCain channeled George Costanza . In a classic episode, the Seinfeld character balks when his fiancée says she's run Source: www.miamiherald.com FDA Sends Letter To Wyeth Over Violative Benefix Flashcard - CNN Money WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration sent a letter to Wyeth (WYE), saying a promotional "flashcard" for the hemophilia drug Benefix is misleading because it suggests Benefix is safer than another drug, CSL's ( CSL.AU Source: money.cnn.com Florida tomato growers seek clear listing from FDA - Miami Herald State tomato growers are appealing to the Food and Drug Administration for losses suffered from the salmonella outbreak. The Florida Tomato Growers Exchange sent the agency a letter Wednesday asking for all of the state's tomatoes to be listed on the Source: www.miamiherald.com Growers want FDA to clear Fla.'s whole tomato crop - Boston Globe ORLANDO, Fla.— Florida tomato growers have asked the U.S. Food and Drug Administration to declare there is no salmonella in the state's tomato crops. The salmonella outbreak began in April, sickening more than 1,000 people in the United States, but Source: www.boston.com China drug regulator: Warning not a ban of drug sales - Xinhua News Agency China drug regulator: Warning not a ban of drug sales - Xinhua News Agency
BEIJING, July 17 (Xinhua) -- China's drug watchdog said Thursday it had not banned drug retailers from selling medicines containing stimulants during Olympics. A spokesman with the State Food and Drug Administration (SFDA) said drugstores should not Source: news.xinhuanet.com Family Sues to Get Experimental Drug - AOL WASHINGTON (July 18) - A Minnesota family is trying to force a New Jersey drug company to give their son an experimental drug for a fatal form of muscular dystrophy, saying he'll die without it. The boy's mother, Cheri Gunvalson, who helped persuade Source: news.aol.com Biocon to market new breast cancer drug in India - New Kerala Bangalore, July 18: Biotechnology major Biocon Ltd will market Abraxane drug of the US-based Abraxis BioScience in India for treating breast cancer, a top company official said here Friday. To be priced at about $400 (Rs.17,200) per 100mg vial in Source: www.newkerala.com A sour taste or sweet embrace? - Times Union Mike Ryan, vice president of W.F. Ryan Produce in Colonie, doesn't want to be one to say "I told you so" when it came to the tomato scare, but he did. When the Food and Drug Administration warned consumers on June 7 that certain tomato varieties may Source: timesunion.com Astellas wins Japan approval for new transplant drug - Reuters TOKYO, July 17 (Reuters) - Astellas Pharma Inc (4503.T: Quote , Profile , Research , Stock Buzz ) said on Thursday it had won approval to sell a new version of its key transplant drug in Japan, the second major region where it has gained approval Source: www.reuters.com OXiGENE Announces Clinical Trials Data to be Presented At the 7th - MSN MoneyCentral ZYBRESTAT (fosbretabulin) is currently being evaluated in a pivotal registration study as a potential treatment for anaplastic thyroid cancer (ATC) under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA). Phase Source: news.moneycentral.msn.com Food safety - Miami Herald Consumers can start eating all types of tomatoes again without worries about getting sick. The Food and Drug Administration on Thursday lifted its salmonella warnings on tomatoes, while advising at risk consumers to limit their consumption of fresh Source: www.miamiherald.com Two US Congress members question Ranbaxy - MSN India New Delhi: Two United States (US) Congress members have expressed doubts over the quality of inspections that are conducted by the US Food and Drugs Administration (FDA) on Indian drug manufacturing facilities before giving them the nod to market Source: news.in.msn.com Celera gets FDA approval for diagnostic software - CNN Money NEW YORK (Associated Press) - Molecular diagnostics company Celera Corp. said Friday the Food and Drug Administration approved new system software used for HIV monitoring and treatment. The new software for the ViroSeq HIV-1 Genotyping system is Source: money.cnn.com July 18, 2008Recalls and Safety Alerts: Update on Potentially Contaminated Heparin Recalls and Safety Alerts: Update on Potentially Contaminated Heparin
Over the past several months, FDA has been alerting healthcare professionals and the public about medical products that may contain contaminated heparin, which has been associated with a number of serious adverse events. Here is an update and recomm... Warning for Regranex—Cream for Leg and Foot Ulcers A boxed warning has been added to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer death in patients who use three or more tubes of the product. 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product Product recalled due to the presence of Burkholderia cepacia. Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. New Medical Products: New Skin Graft Adhesive Approved FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi... Electronic Medical Devices Possible malfunction of Electronic Medical Devices caused by Computed Tomography (CT) Scanning on patients with implanted and external electronic medical devices. April 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. New Medical Products: New Non-Refrigerated Coagulation Product FDA has approved a new formulation of the genetically engineered version of Factor VIIa that does not need to be refrigerated. Factor VIIa is a plasma protein essential for blood clotting that can be used to treat and prevent bleeding in people with... Preventing Medical Errors: Preventing Fatal Overdoses with Cerebyx The Institute for Safe Medication Practices (ISMP) and FDA are warning healthcare professionals that potentially fatal dosing errors continue to occur with the anti-epileptic drug Cerebyx (fosphenytoin), despite clarifications in the drug's labeling ... Myfortic (mycophenolate acid) Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic. FDA Food Protection Plan Shows Significant Progress FDA Food Protection Plan Shows Significant Progress
The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007. Administration Proposes Additional Funding for FDA to Improve Food and Medical Product Safety (HHS Release) HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA. Beware of Online Cancer Fraud FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice. FDA Approves Diaphragm-Pacing Device The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator. Your Guide to Reporting Problems to FDA This guide provides tips and a quick-reference chart to help you report a problem to FDA. New Medical Products: New Skin Graft Adhesive Approved FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi... Making Sense of Vytorin Concerns This article clarifies the results of a study that was published in the New England Journal of Medicine, and emphasizes the importance of continuing on prescribed cholesterol medications. FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals
The U.S. Food and Drug Administration (FDA) today announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency. FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again FDA Revises Process for Responding to Drug Applications The U.S. Food and Drug Administration announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted. New Medical Products: New Skin Graft Adhesive Approved FDA recently approved a new medical adhesive called Artiss to attach skin grafts onto burn patients. Artiss is made by Baxter Healthcare. Artiss has a lower thrombin concentration than other fibrin sealants, which gives surgeons more time to posi... Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. FDA Approves New Genetic Test for Patients with Breast Cancer The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab). FDA Reaches Settlement with California Hearing Device Maker The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law. Drug Shortage: Fentanyl transdermal patch Availability information updated. Drug to be Discontinued: Kemadrin (procyclidine hydrochloride) Kemadrin (procyclidine hydrochloride), Dear Healthcare Professional Letter available for more information. Growers want FDA to clear Fla.'s whole tomato crop - Miami Herald Growers want FDA to clear Fla.'s whole tomato crop - Miami Herald
ORLANDO, Fla. Florida tomato growers have asked the U.S. Food and Drug Administration to declare there is no salmonella in the state's tomato crops. The salmonella outbreak began in April, sickening more than 1,000 people in the United States, but Source: www.miamiherald.com April 2008 Monthly Safety Labeling April 2008 Monthly Safety Labeling
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. May 2008 Monthly Safety Labeling Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides. Resolved Drug Shortage: Digoxin oral tablets See website for more information about this resolved shortage. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Red Tomato Warning Expanded Nationwide Red Tomato Warning Expanded Nationwide
The Food and Drug Administration is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, red Roma, and red round tomatoes, and products containing these tomatoes. Wrinkle Relief: Injectable Cosmetic Fillers Injectable wrinkle fillers can restore a smoother appearance to your face, but here's what to consider before having this cosmetic procedure done. How to Dispose of Unused Medicines Is your medicine cabinet filled with expired or unused drugs? Here's how to dispose of them. FDA 101: How to Use the Consumer Complaint System and MedWatch When you have a problem with a food, drug, or other FDA-regulated product, FDA wants to hear from you. Here's how to report problems using two of FDA's main reporting systems. FDA 101: Biological Products Basic facts about biologics, products that replicate natural biologic substances such as enzymes, antibodies, or hormones in our bodies. FDA 101: Advisory Committees FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees. Your Guide to Reporting Problems to FDA This guide provides tips and a quick-reference chart to help you report a problem to FDA. FDA declares it's OK to eat tomatoes again - Forbes FDA declares it's OK to eat tomatoes again - Forbes
It's OK to eat all kinds of tomatoes again, the U.S. government declared Thursday - lifting its salmonella warning on the summer favorites amid signs that the record outbreak, while not over, may finally be slowing. Hot peppers still get a caution Source: www.forbes.com FDA Panel: J&J's Doribax Effective For Nosocomial Pneumonia - CNN Money Rockville, Md. -(Dow Jones)- Johnson & Johnson's (JNJ) antibiotic Doribax appears effective enough to treat pneumonia for patients on mechanical ventilation units, a panel of medical experts told federal regulators Wednesday. Panel members, however Source: money.cnn.com FDA gives OK to tomatoes, continues warning on peppers - Newsday WASHINGTON - The federal government declared it's OK to eat tomatoes again, amid an ongoing outbreak of Salmonella Saintpaul but with signs that - while not over - it may be slowing. Food and Drug Administration officials reiterated earlier warnings Source: www.newsday.com FDA gives all-clear on tomatoes, not peppers - Chicago Tribune WASHINGTON — The Food and Drug Administration declared on Thursday that it is again safe to eat all tomatoes now on sale in the U.S., canceling its warning in June that some tomatoes were the cause of a still-unsolved outbreak of salmonella Source: www.chicagotribune.com FDA unveils plan to recruit young science staffers - CNN Money NEW YORK (Associated Press) - The Food and Drug Administration has unveiled a plan for recruiting young staffers to replace the hundreds of scientists retiring from the agency. The FDA said Thursday it will launch a two-year fellowship program for Source: money.cnn.com FDA eases tomato warning - Baltimore Sun WASHINGTON - After warning Americans for six weeks against eating certain kinds of tomatoes, federal health officials gave the all-clear yesterday - without ever finding solid evidence that tomatoes were the cause of the largest outbreak of food Source: www.baltimoresun.com Florida tomato growers seek clear listing from FDA - Miami Herald State tomato growers are appealing to the Food and Drug Administration for losses suffered from the salmonella outbreak. The Florida Tomato Growers Exchange sent the agency a letter Wednesday asking for all of the state's tomatoes to be listed on the Source: www.miamiherald.com FDA declares it's OK to eat tomatoes again - Miami Herald WASHINGTON -- The U.S. government has declared it's OK to eat tomatoes again, lifting its salmonella warning amid signs that the outbreak - while not over - may finally be slowing. Officials reiterated earlier warnings that the people most at risk of Source: www.miamiherald.com Celera gets FDA approval for diagnostic software - CNN Money NEW YORK (Associated Press) - Molecular diagnostics company Celera Corp. said Friday the Food and Drug Administration approved new system software used for HIV monitoring and treatment. The new software for the ViroSeq HIV-1 Genotyping system is Source: money.cnn.com Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27) Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation (June 27)
As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2 Percent Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2 Percent CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia). Fresca Italia, Inc., Expands Recall of Burrata Cheese Because of Possible Health Risk (June 23) Fresca Italia is recalling Burrata, a type of cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as fever, headache, stiffness, nausea, abdominal, or diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. FDA declares it's OK to eat tomatoes again - Forbes FDA declares it's OK to eat tomatoes again - Forbes
It's OK to eat all kinds of tomatoes again, the U.S. government declared Thursday - lifting its salmonella warning on the summer favorites amid signs that the record outbreak, while not over, may finally be slowing. Hot peppers still get a caution Source: www.forbes.com FDA eases tomato warning - Baltimore Sun WASHINGTON - After warning Americans for six weeks against eating certain kinds of tomatoes, federal health officials gave the all-clear yesterday - without ever finding solid evidence that tomatoes were the cause of the largest outbreak of food Source: www.baltimoresun.com Growers want FDA to clear Fla.'s whole tomato crop - Miami Herald ORLANDO, Fla. Florida tomato growers have asked the U.S. Food and Drug Administration to declare there is no salmonella in the state's tomato crops. The salmonella outbreak began in April, sickening more than 1,000 people in the United States, but Source: www.miamiherald.com FDA declares tomatoes safe, but peppers not off the hook - Philadelphia Inquirer WASHINGTON - It's OK to eat all kinds of tomatoes again, the U.S. government declared yesterday - lifting its salmonella warning on the summer favorites amid signs that the record outbreak, while not over, may finally be slowing. Hot peppers still Source: www.philly.com FDA: Salmonella cases not linked to tomatoes - AZCentral.com Federal officials said Thursday that all tomatoes on the U.S. market are safe to eat but they still don't know what's causing a salmonella outbreak that's sickened thousands over the past three months. Jalapeno and serrano peppers remain the focus of Source: www.azcentral.com FDA protecting wrong party - Philadelphia Inquirer Richard Golomb is a past president of the Philadelphia Trial Lawyers Association More than 200 years ago, America's greatest patriots convened to write a document that would empower us all with inalienable rights, liberties and freedoms. But on this Source: www.philly.com FDA gives OK to tomatoes, continues warning on peppers - Newsday WASHINGTON - The federal government declared it's OK to eat tomatoes again, amid an ongoing outbreak of Salmonella Saintpaul but with signs that - while not over - it may be slowing. Food and Drug Administration officials reiterated earlier warnings Source: www.newsday.com FDA Grants Clearance for Celera's ViroSeq(R) HIV-1 Genotyping System - MSN MoneyCentral Celera CRA today announced that it has received marketing clearance from the U.S. Food and Drug Administration for its 510(k) submission of the ViroSeq HIV-1 Genotyping System Software v2.8. The ViroSeq HIV-1 Genotyping ™ System is designed to Source: news.moneycentral.msn.com FDA Panel: J&J's Doribax Effective For Nosocomial Pneumonia - CNN Money Rockville, Md. -(Dow Jones)- Johnson & Johnson's (JNJ) antibiotic Doribax appears effective enough to treat pneumonia for patients on mechanical ventilation units, a panel of medical experts told federal regulators Wednesday. Panel members, however Source: money.cnn.com Salmonella warnings lifted on tomatoes - Miami Herald Salmonella warnings lifted on tomatoes - Miami Herald
Consumers can start eating all types of tomatoes again without worries about getting sick. The Food and Drug Administration on Thursday lifted its salmonella warnings on tomatoes, while advising at risk consumers to limit their consumption of fresh Source: www.miamiherald.com FDA eases tomato warning - Baltimore Sun WASHINGTON - After warning Americans for six weeks against eating certain kinds of tomatoes, federal health officials gave the all-clear yesterday - without ever finding solid evidence that tomatoes were the cause of the largest outbreak of food Source: www.baltimoresun.com FDA gives OK to tomatoes, continues warning on peppers - Newsday WASHINGTON - The federal government declared it's OK to eat tomatoes again, amid an ongoing outbreak of Salmonella Saintpaul but with signs that - while not over - it may be slowing. Food and Drug Administration officials reiterated earlier warnings Source: www.newsday.com FDA: Salmonella cases not linked to tomatoes - AZCentral.com Federal officials said Thursday that all tomatoes on the U.S. market are safe to eat but they still don't know what's causing a salmonella outbreak that's sickened thousands over the past three months. Jalapeno and serrano peppers remain the focus of Source: www.azcentral.com Growers want FDA to clear Fla.'s whole tomato crop - Miami Herald ORLANDO, Fla. Florida tomato growers have asked the U.S. Food and Drug Administration to declare there is no salmonella in the state's tomato crops. The salmonella outbreak began in April, sickening more than 1,000 people in the United States, but Source: www.miamiherald.com FDA says tomatoes are safe; peppers suspect - Seattle Times WASHINGTON — It's OK to eat all kinds of tomatoes again, the U.S. government declared Thursday — lifting its salmonella warning amid signs the record outbreak, while not over, finally may be slowing. Hot peppers still get a caution: The people Source: seattletimes.nwsource.com FDA declares it's OK to eat tomatoes again - Boston Globe WASHINGTON— It's OK to eat all kinds of tomatoes again, the U.S. government declared Thursday -- lifting its salmonella warning on the summer favorites amid signs that the record outbreak, while not over, may finally be slowing. Hot peppers still Source: www.boston.com Growers want FDA to clear Fla.'s whole tomato crop - Miami Herald Growers want FDA to clear Fla.'s whole tomato crop - Miami Herald
ORLANDO, Fla. Florida tomato growers have asked the U.S. Food and Drug Administration to declare there is no salmonella in the state's tomato crops. The salmonella outbreak began in April, sickening more than 1,000 people in the United States, but Source: www.miamiherald.com Allergy Drug Turned Alzheimer's Therapy Shows Promise - ABC News A pill once used as an antihistamine in Russia has shown a slight but unique promise for treating Alzheimer's disease and is now on a fast track to drug studies in the United States. A Russian drug called Dimebon is showing promise in early clinical Source: www.abcnews.go.com Across the nation - Detroit Free Press Tomatoes sold in the United States are safe to eat now, the Food and Drug Administration said Thursday, lifting its warning about the risk of salmonella contamination. But the FDA reiterated warnings that people most at risk should avoid jalapeno and Source: www.freep.com China has 64,000 drug supervision officials - Xinhua News Agency BEIJING, July 18 (Xinhua) -- China reported 64,000 drug supervision officials working for 2,692 drug regulatory departments by the end of 2007, said a white paper published on Friday by the Information Office of the State Council. Meanwhile, China Source: news.xinhuanet.com AGI Therapeutics says on track for data on 'Rezular' from Phase III in - CNBC LONDON (Thomson Financial) - AGI Therapeutics Plc. said it believes it is on track to report preliminary data from its ongoing Phase III efficacy study for its 'Rezular' drug, in the first half of 2009. The company said it met with the U.S. Food and Source: www.cnbc.com China's drug supervision is ready for the Olympics - Xinhua News Agency BEIJING, July 18 (Xinhua) -- China's drug supervision system is ready for the Olympics, a drug watchdog spokeswoman said on Friday. China has intensified inspection and testing measures for drugs to safeguard drug safety for Olympic athletes, the Source: news.xinhuanet.com Salmonella warnings lifted on tomatoes - Miami Herald Consumers can start eating all types of tomatoes again without worries about getting sick. The Food and Drug Administration on Thursday lifted its salmonella warnings on tomatoes, while advising at risk consumers to limit their consumption of fresh Source: www.miamiherald.com New Medical Products: New Non-Refrigerated Coagulation Product New Medical Products: New Non-Refrigerated Coagulation Product
FDA has approved a new formulation of the genetically engineered version of Factor VIIa that does not need to be refrigerated. Factor VIIa is a plasma protein essential for blood clotting that can be used to treat and prevent bleeding in people with... July 17, 2008Resolved Drug Shortage: Digoxin oral tablets Resolved Drug Shortage: Digoxin oral tablets
See website for more information about this resolved shortage. Sodium Polystyrene Sulfonate Suspension Recall of 2 lots of the product due to the presence of yeast which could affect patients who are immunocompromised. Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP) Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP)
Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP. Dear Healthcare Professional Letter is available for more information. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Current Drug Shortage: Levothyroxine sodium lyophilized powder for injection. Bedford has the 200 mcg vials (NDC 55390-0880-10) available. APP plans to have levothyroxine vials available again Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection) Baxter has discontinued Revex production. Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17) Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1) Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10). Recalls and Safety Alerts: FDA Takes Action on Injectable Colchicine FDA is taking action against companies marketing injectable colchicine, which is an unapproved form of the drug. Colchicine is an anti-inflammatory used in the treatment of gout. Colchicine tablets, which are less hazardous, are not affected by FDA... Family sues for trial muscular dystrophy drug - CNBC Family sues for trial muscular dystrophy drug - CNBC
WASHINGTON - A Minnesota family is trying to force a New Jersey drug company to give their son an experimental drug for a fatal form of muscular dystrophy, saying he'll die without it. The boy's mother, Cheri Gunvalson, who helped persuade Congress Source: www.cnbc.com FDA lifts warning on tomatoes - CNN (CNN) -- Tomatoes are again safe to eat, the Food and Drug Administration said Thursday, weeks after the food was blamed as a source of a salmonella outbreak in the United States and Canada. The source of the outbreak of salmonella still isn't known Source: www.cnn.com Connecticut receiving $2 million drug maker case - Boston Globe HARTFORD, Conn.— Attorney General Richard Blumenthal says Connecticut will be receiving almost $2 million as part of a national settlement with drug maker Bristol-Myers Squibb . The agreement settles allegations that the company and a former Source: www.boston.com Family sues co. for muscular dystrophy drug - San Francisco Gate A Minnesota family is trying to force a New Jersey drug company to give their son an experimental drug for a fatal form of muscular dystrophy, saying he'll die without it. The boy's mother, Cheri Gunvalson, who helped persuade Congress to Source: www.sfgate.com Eating tomatoes is safe again despite salmonella outbreak - Los Angeles Times WASHINGTON -- It's OK to eat all kinds of tomatoes again, the U.S. government declared Thursday -- lifting its warning on the summer favorite amid signs that the Salmonella Saintpaul outbreak, while not over, may finally be slowing. Hot peppers still Source: www.latimes.com FDA Clears Suspect Tomatoes - ABC News The Food and Drug Administration lifted its tomato alert today despite uncertainty about what caused so many illnesses in recent months. Officials cleared tomatoes because the farms that may have shipped them at the beginning of the outbreak in May Source: abcnews.go.com China has 64,000 drug supervision officials - Xinhua News Agency BEIJING, July 18 (Xinhua) -- China reported 64,000 drug supervision officials working for 2,692 drug regulatory departments by the end of 2007, said a white paper published on Friday by the Information Office of the State Council. Meanwhile, China Source: news.xinhuanet.com Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion
Reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein when used in the cervical spine. Radiology and Children: Extra Care Required Radiology and Children: Extra Care Required
Image Gently, a campaign launched this year, aims to raise awareness about opportunities to lower the radiation dose during the medical imaging of children. Drug to be Discontinued: Kemadrin (procyclidine hydrochloride) Kemadrin (procyclidine hydrochloride), Dear Healthcare Professional Letter available for more information. FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures' Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet. Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial Resolved Drug Shortage: Leukine (sargramostim) liquid 500 mcg vial FDA Lifts Warning About Eating Certain Types of Tomatoes After a lengthy investigation, the FDA has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency is removing its June 7 warning against eating certain types of red raw tomatoes. FDA Approves First Generic Risperidone to Treat Psychiatric Conditions The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions. FDA Approves New Genetic Test for Patients with Breast Cancer The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab). FDA Reaches Settlement with California Hearing Device Maker The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law. Stay Healthy While Traveling Abroad Getting sick can ruin your trip. FDA shares the guidance it gives to overseas inspectors to help them remain healthy while traveling abroad. FDA 101: Advisory Committees FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees. FDA Food Protection Plan Shows Significant Progress FDA Food Protection Plan Shows Significant Progress The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America's food supply since unveiling its Food Protection Plan in November 2007. FDA Requests Seizure of Animal Food Products at PETCO Distribution Center At the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago. |
