October 4, 2008
 

FDA Takes End Run to Award PR Contract - Washington Post


FDA Takes End Run to Award PR Contract - Washington Post
The U.S. Food and Drug Administration had an image problem. For months last year the agency had been pummeled by Congress for poor inspections of tainted vegetables, drugs and other products. FDA leaders decided to hire a contractor for a public
Source: www.washingtonpost.com

FDA Rules How Much Melamine Is Too Much - KVIA.com
FRIDAY, Oct. 3 (HealthDay News) -- With the Chinese milk products-melamine scandal generating fresh headlines, U.S. health officials on Friday unveiled what they consider acceptable levels of contamination with the industrial chemical. The bottom
Source: www.kvia.com

TorreyPines Therapeutics Reports Successful End-of-Phase II Meeting - MSN MoneyCentral
LA JOLLA, Calif. , Oct. 1 /PRNewswire/ -- TorreyPines Therapeutics, Inc. TPTX today announced that it held a successful End-of-Phase II meeting for tezampanel with the U.S. Food and Drug Administration (FDA) on September 29, 2008 . Based on a review
Source: news.moneycentral.msn.com

BRIEF-Bristol says FDA approves HIV treatment - Forbes
Copyright Thomson Financial News Limited 2008. 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

UPDATE 1-NeuroMetrix gets FDA nod for device, shares jump - Reuters
Oct 2 (Reuters) - Medical device maker NeuroMetrix Inc (NURO.O: Quote , Profile , Research , Stock Buzz ) said the U.S. health regulators approved the use of its Universal electrodes in nerve conduction studies, sending its shares up as much as 83
Source: www.reuters.com

FDA exploring safety of children's cough and cold medicines - Boston Globe
Federal regulators tomorrow will explore setting new standards for over-the-counter cough and cold remedies intended for children. A year after manufacturers voluntarily pulled the medicines for children under 2 off store shelves, the Food and Drug
Source: www.boston.com

 

FDA Issues Health Information Advisory on Infant Formula


FDA Issues Health Information Advisory on Infant Formula
In response to reports of contaminated milk-based infant formula manufactured in China, the U.S. Food and Drug Administration (FDA) today is issuing a Health Information Advisory. This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States. Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community.

FDA Awards $5.2 Million in Grants to Further Food and Feed Safety
The U.S. Food and Drug Administration today announced the awarding of 17 grants to enhance food and feed safety. These grants fund major cooperative agreements in four major areas. The FDA awarded a combined $5.2 million in these one-year grants to various state and local regulatory agencies.

FDA Updates Health Information Advisory on Melamine Contamination
The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine.

FDA: West Virginia Livestock Owner Sentenced in Criminal and Civil Contempt Case
The U.S. Food and Drug Administration announced today that a West Virginia cattle dealer has been sentenced to six months probation for refusing to obey court orders in 2006 and 2008 that prohibited her from introducing animals into the food supply until the FDA had approved her record-keeping system. The FDA initiated the case after illegal levels of drug residue were found repeatedly in calves that Shirley A. Rhodes of Sandyville sold for use as human food.

FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of Lou Gehrig's Disease
A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as Lou Gehrig's Disease.

Recalls and Safety Alerts: Update on Cardiopulmonary Reactions with Ultrasound Micro-bubble Contrast Agents
FDA is alerting healthcare professionals about labeling changes for ultrasound micro-bubble contrast agents, which are sold as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injec...

 

S.Korea finds melamine in China-made Snickers,KitKat - Yahoo News


S.Korea finds melamine in China-made Snickers,KitKat - Yahoo News
SEOUL (Reuters) - South Korea's food watchdog has ordered China -manufactured snacks from Nestle SA and Mars Inc to be taken off shelves after detecting melamine in their samples, it said on Saturday. The Korea Food and Drug Administration (KFDA
Source: news.yahoo.com

 

Faces sag along with economy - Detroit News


Faces sag along with economy - Detroit News
CHICAGO -- The economy isn't the only thing that's drooping -- so are faces, breasts and bellies as would-be cosmetic surgery patients increasingly opt against costly nips and tucks because of tough financial times. Anecdotal reports and a recent
Source: www.detnews.com

FDA: Tiny Bit of Melamine OK in Most Foods - Fox Birmingham
WASHINGTON -- Tiny traces of melamine, the chemical that has set off a global food safety scare , are not harmful in most foods, except baby formula, government experts said Friday. The Food and Drug Administration said Friday its safety experts have
Source: www.myfoxal.com

FDA: No Amount Of Melamine Safe In Formula - Post Chronicle
The U.S. Food and Drug Administration said even a tiny amount of melamine in infant formula poses a risk. A tainted milk scandal in China prompted the agency to conduct a safety and risk assessment to identify the level of melamine and melamine
Source: www.postchronicle.com

FDA Wants More Time to Study Cold Meds for Kids - Atlanta Journal Constitution
THURSDAY, Oct. 2 (HealthDay News) -- The U.S. Food and Drug Administration will take its time considering whether to ban over-the-counter cold medicines for children, a top agency official said Thursday at a public hearing on the matter. Dr. John
Source: www.ajc.com

Northfield seeks priority FDA review of blood substitute - Chicago Tribune
Northfield Laboratories Inc. would like the U.S. Food and Drug Administration to convene a panel of advisers possibly early next year to conduct a speedy review of its experimental blood substitute. The Evanston -based biotech company plans to update
Source: www.chicagotribune.com

High court term begins quietly in campaign season - Boston Globe
WASHINGTON— The Supreme Court is doing its best to stay out of the spotlight in the final days of the presidential campaign and while the other two branches of government struggle to deal with turmoil in the financial markets. The justices open
Source: www.boston.com

FDA Takes End Run to Award PR Contract - Washington Post
The U.S. Food and Drug Administration had an image problem. For months last year the agency had been pummeled by Congress for poor inspections of tainted vegetables, drugs and other products. FDA leaders decided to hire a contractor for a public
Source: www.washingtonpost.com

Assurance by FDA on melamine - Baltimore Sun
WASHINGTON - Tiny traces of melamine, the chemical that has set off a global food-safety scare, are not harmful in most foods, although it poses a threat when found in baby formula, government experts said yesterday. The Food and Drug Administration
Source: www.baltimoresun.com

 

In-Body Pediatric Devices Pose Unique Challenges


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.

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.

Vaccines Stand Ready for Flu Season
FDA has approved six vaccines for the 2008-2009 flu season.

Lion Pavilion Issues Alert on Undeclared Sulfites in Yulanpian Brand Dried Slices of Tender Bamboo Shoots (September 26)
Yulanpian Brand Dried Slices of Tender Bamboo Shoots is sold in a 230gram, clear plastic package with the following code: 2008.1.3 and was distributed nationwide. It is a product of China.

Mr. Brown 3-In-1 and and 2-In-1 Powdered Packets in Bag Coffee Mixes Due To Health Risk (October 1)
The recall was initiated after the manufacturer notified Sunny Maid that these 3-in-1 and 2-in-1 Coffee Mix products may contain melamine. Although only certain lots are potentially contaminated, Sunny Maid is recalling all lots. No illnesses associated with this product have been reported to date.

Sprouters Northwest, Inc. Recalls Alfalfa Sprout Products Because of Possible Health Concern (September 5)
Sprouters Northwest, Inc. of Kent, Washington is recalling its alfalfa sprout products (alfalfa sprouts, onion sprouts, and salad sprouts) because they may be linked to a recent outbreak of Salmonellosis in Oregon and Washington State. To date, 13 cases of Salmonella Typhimirium infection have been associated with the consumption of raw alfalfa sprouts.

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...

Tristar Food Wholesale Co Inc. Issues a Nationwide recall of Blue Cat Flavor Drink Because of Possible Health Risk (October 3)
Tristar Food, Jersey City, NJ is initiating a nationwide recall of all of their 100 ml plastic bottle packages of Blue Cat Flavor Drink (Lanmao) because it may be contaminated with Melamine.

 

Bombay HC sets aside Maharashtra FDA orders on Subhiksha - Business Standard


Bombay HC sets aside Maharashtra FDA orders on Subhiksha - Business Standard
The decision in this regard was taken by a bench of the Mumbai High Court on Friday, Subhiksha said in a statement. Maharashtra government's regulatory body for food and drugs, Maharastra FDA, had in mid-August passed orders of cancellation of
Source: www.business-standard.com

Stewart subpoena not ruled out - Baltimore Sun
WASHINGTON - Lawmakers leading an investigation of Martha Stewart's sale of ImClone Systems Inc. stock aren't ruling out issuing a subpoena to force her to appear on Capitol Hill. "It may be the only means to get her to come forward and tell her
Source: www.baltimoresun.com

FDA sets melamine guide to help in food-safety tests - Arizona Daily Star
WASHINGTON — Tiny traces of melamine, the chemical that has set off a global food-safety scare, are not harmful in most foods, except baby formula, government experts said Friday. The Food and Drug Administration said its safety experts have
Source: www.azstarnet.com

Bombay HC sets aside FDA order against Subhiksha warehouse - Economic Times
NEW DELHI: Bombay High Court on Friday set aside all the orders of the FDA in respect of the Bhiwandi Mumbai Warehouse of Subhiksha. FDA had in August this year passed orders of cancellation of license against 3 of Subhiksha’s Vendors and a 20 day
Source: economictimes.indiatimes.com

FDA: Bit of melamine all right in most foods - AZCentral.com
WASHINGTON - Tiny traces of melamine, the chemical that has set off a global food-safety scare, are not harmful in most foods, except baby formula, government experts said Friday. The Food and Drug Administration said Friday that its safety experts
Source: www.azcentral.com

 

Faces sag along with economy - Detroit News


Faces sag along with economy - Detroit News
CHICAGO -- The economy isn't the only thing that's drooping -- so are faces, breasts and bellies as would-be cosmetic surgery patients increasingly opt against costly nips and tucks because of tough financial times. Anecdotal reports and a recent
Source: www.detnews.com

Melamine traces OK, FDA asserts - Boston Globe
WASHINGTON - Tiny traces of melamine, the chemical that has set off a global food safety scare, are not harmful in most foods, except baby formula, the FDA said yesterday. The Food and Drug Administration said its safety specialists have concluded
Source: www.boston.com

FDA: Tiny Traces Of Chemical Are OK - Hartford Courant
WASHINGTON — - Tiny traces of melamine, the chemical that has set off a global food safety scare, are not harmful in most foods, except baby formula, government experts said Friday. The Food and Drug Administration said Friday that its safety
Source: www.courant.com

October 3, 2008
 

FDA Awards up to $2.5 Billion to Modernize Information Technology over Ten Years


FDA Awards up to $2.5 Billion to Modernize Information Technology over Ten Years
The U.S. Food and Drug Administration today announced the selection of ten contractors to receive up to a total of $2.5 billion for information technology (IT) and data center management services over the next ten years.

Voluntary Recall: Wegmans In-Store Made Bagels (September 10)
Wegmans Food Markets, Inc. is voluntarily recalling all varieties of its in-store made bagels and bialys (flattened bagels with various toppings, i.e. pizza) sold in the bakery and purchased between August 24 and September 9, 2008. This recall is being initiated because the bagels may contain pieces of a metal spring from a mixer that entered the dough, which is produced at Wegmans' Central Bakeshop in Rochester, posing a possible choking hazard.

Drug Shortage: Drug to be Discontinued; Revex (Nalmefene HCl Injection)
Baxter has discontinued Revex production.

Wegmans Expands Dates of Bagel Recall and Includes Additional Bakery Products (September 11)
Wegmans Food Markets, Inc. has expanded the voluntary recall of in-store made bagels and bialys first announced on Wednesday, September 10. The recall is now expanded to include Challah bread and in-store baked bagels, bialys and rolls. These products were sold in Wegmans' bakery department between June 19 and September 11, 2008.

FDA Updates Health Information Advisory on Melamine Contamination
The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine.

FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections
The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died.

FDA Approves DNA Test to Measure Hepatitis B Virus Levels
The U.S. Food and Drug Administration today approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient's blood. Assessing a patient's viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections.

QFCO, Inc. Recalls White Rabbit Candy Because of Possible Health Risk (September 26)
QFCO, Inc. of Burlingame, California is recalling White Rabbit Candy because it may be contaminated with Melamine. Product was distributed to the states of CA, GA, HI, IL, MN, NY, OR, TX, WA through wholesale distributors to retail stores.

The Hershey Company Announces Nationwide Voluntary Recall of Hershey's Chocolate Shell Topping Due to Undeclared Almonds (September 4)
The only 7.25-ounce bottles of Hershey's Chocolate Shell Topping affected have the code 69N printed on the back of the bottle below the UPC symbol. The UPC/Bar Code is 346000. The item in question was available for purchase nationwide after July 8, 2008.

 

FDA: Tiny bit of melamine OK in most foods - Boston Globe


FDA: Tiny bit of melamine OK in most foods - Boston Globe
WASHINGTON— Tiny traces of melamine, the chemical that has set off a global food safety scare, are not harmful in most foods, except baby formula, government experts said Friday. The Food and Drug Administration said Friday its safety experts have
Source: www.boston.com

September 29, 2008
 

US FDA: No Lou Gehrig's disease risk with statins - Guardian Unlimited


US FDA: No Lou Gehrig's disease risk with statins - Guardian Unlimited
WASHINGTON, Sept 29 (Reuters) - An analysis of dozens of studies found the widely used statin cholesterol drugs do not increase the risk of Lou Gehrig's disease, U.S. health officials said on Monday. The U.S. Food and Drug Administration said it
Source: www.guardian.co.uk

Lilly says FDA widens use of cancer drug Alimta - Forbes
Eli Lilly & Co. said Monday the Food and Drug Administration has approved the use of Lilly's drug Alimta as a first-line treatment for advanced and metastasized non-small cell lung cancer. The drug maker said Alimta was approved as an initial
Source: www.forbes.com

FDA: Statins Don't Increase 'Lou Gehrig s' Risk - CNN Money
WASHINGTON -(Dow Jones)- The Food and Drug Administration said Monday the use of cholesterol-lowering drugs known as statins do not appear to increase the risk of amyotrophic lateral sclerosis, or ALS, a condition more commonly known as Lou Gehrig's
Source: money.cnn.com

UPDATE 1-US FDA: No Lou Gehrig's disease risk with statins - Reuters
WASHINGTON, Sept 29 (Reuters) - An analysis of dozens of studies found the widely used statin cholesterol drugs do not increase the risk of Lou Gehrig's disease, U.S. health officials said on Monday. The U.S. Food and Drug Administration said it
Source: www.reuters.com

FDA Funding Will Increase in Tough Budget Year - Forbes
The Alliance for a Stronger FDA today applauded Congressional actions to assure increased funding for FDA in fiscal year 2009. Under the Continuing Resolution (CR), FDA will be able to spend at a higher rate in FY 2009 than it did in the current
Source: www.forbes.com

FDA says changes coming in wake of critical report - Newsweek
The nation's fresh produce would be safer if U.S. farmers were required to adopt strict standards for growing leafy greens similar to industry-written ones devised for California growers, a Food and Drug Administration official said Friday. Dr. David
Source: www.newsweek.com

 

Cephalon to pay $425 mln to settle gov't probes - Forbes


Cephalon to pay $425 mln to settle gov't probes - Forbes
BOSTON (Reuters) - Cephalon Inc (nasdaq: CEPH - news - people ) will pay $425 million to settle criminal and civil charges that it illegally promoted three of its drugs, the U.S. Department of Justice said Monday. The company and U.S. officials have
Source: www.forbes.com

Movers roundup: Halliburton, Eli Lilly - CNN Money
HOUSTON (AP) _ Halliburton shares slumped Monday as the oil services company warned that earnings and revenue would take a hit from hurricanes Gustav and Ike. NEW YORK (AP) _ Shares of Eli Lilly & Co. fell Monday following the company's Friday
Source: money.cnn.com

Lilly says FDA widens use of cancer drug Alimta - Indianapolis Star
Eli Lilly and Co. said today the Food and Drug Administration has approved the use of Lilly's drug Alimta as a first-line treatment for advanced and metastasized non-small cell lung cancer. The Indianapolis-based drug maker said Alimta was approved
Source: www.indystar.com

 

FDA cites Procrit, Eprex and Eopgen study - United Press International


FDA cites Procrit, Eprex and Eopgen study - United Press International
WASHINGTON, Sept. 29 (UPI) -- The U.S. Food and Drug Administration issued an advisory about preliminary results of a German study involving the drug known as Procrit, Eprex or Epogen. The federal agency said the German study is investigating whether
Source: www.upi.com

 

RPT Eli Lilly says FDA continues to review Prasugrel as Sept 26 goal - Forbes


RPT Eli Lilly says FDA continues to review Prasugrel as Sept 26 goal - Forbes
LONDON (Thomson Financial) - Eli Lilly and Co (nyse: LLY - news - people ) said the U.S. Food and Drug Administration continues to review its new drug application (NDA) for Prasugrel, after the agency failed to complete its review by the Sept 26
Source: www.forbes.com

U.S. FDA Selects Applied Biosystems (ABI) to Provide Mass Spectrometry - StreetInsider.com
Applied Biosystems Inc. (NYSE: ABI ) announced that the U.S. Food and Drug Administration has purchased seven of the company's 4000 QTRAP(R) Systems for the analysis of potential harmful pesticides in the U.S. food supply. These systems will be
Source: www.streetinsider.com

CEPHEID GETS FDA OK TO MARKET XPERT MRSA/SA SKIN AND SOFT TISSUE - 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 Warns Anemia Drugs Linked To Deaths In Stroke Patients - dbtechno.com
Washington (dbTechno) - The U.S. Food and Drug Administration (FDA) has put out a warning saying that stroke patients who use anemia drugs may be increasing their risk of death. The news comes as preliminary results from a German study were released
Source: www.dbtechno.com

Cepheid receives marketing clearance from FDA for Xpert MRSA/SA SSTI - RTT News
(RTTNews) - Cepheid, Inc. (CPHD: News ), a molecular diagnostics company, said Monday that it received clearance from the U.S Food and Drug Administration, or FDA, to market its Xpert MRSA/SA Skin and Soft Tissue Infection, or SSTI, test that runs on
Source: www.rttnews.com

Report Slams FDA On Lack Of Fresh Produce Oversight - dbtechno.com
Washington (dbTechno) - The Government Accountability Office (GAO) has put out a new report, slamming the FDA for an overall lack of oversight of fresh produce. The new report released by the GAO has gone after the U.S. Food and Drug Administration
Source: www.dbtechno.com

Cepheid Receives FDA Clearance for First Rapid On-Demand Molecular - MSN MoneyCentral
Physicians and Surgeons Can Now Diagnose MRSA & SA Soft Tissue Infections in Less Than One Hour, Leading to More Effective Treatment SUNNYVALE, Calif. , Sept. 29 /PRNewswire-FirstCall/ -- Cepheid CPHD today announced it has received clearance from
Source: news.moneycentral.msn.com

Cleveland BioLabs to Present at Maxim Group Growth Conference - MSN MoneyCentral
Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that the Company is scheduled to present at the Maxim Group Growth Conference in New York City on Tuesday, October 7, 2008. The conference will be held at the Grand Hyatt New York Hotel. The
Source: news.moneycentral.msn.com

FDA cracks down on unapproved drugs - Citizen
WASHINGTON (AP) _ Federal officials on Tuesday launched a crackdown against several companies that market an eye wash and a widely used skin cream without government approval, saying these prescription medications could pose risks. The eye wash
Source: www.citizen.com

FDA Probes J&J Anemia Drug over Clinical Trial Deaths - Eflux Media
Results of a study undergone by German scientists revealed that stroke patients given Amgen and Johnson & Johnson’s anemia drug Eprex might increase their risk for death, the US Food and Drug Administration warned on Friday. Eprex belongs to a
Source: www.efluxmedia.com

September 28, 2008
 

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.

Trans Ocean Products Recalls Cracked Pepper Style Smoked Salmon LOT No 54933-2 Because of Possible Health Risks (August 29)
Trans-Ocean Products, Inc. of Bellingham, Washington is recalling its 4 ounce Cracked Pepper Style Smoked Salmon Lot No 54933-2 because it has the potential to be contaminated with Listeria monocytogenes, an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Are You Storing Food Safely?
When, where, and how you store food can help prevent foodborne illnesses. Here are pointers for safely storing food in your refrigerator, freezer, and cupboards.

 

FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers


FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers
The U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. These two HPV types cause 70 percent of cervical cancers, and are known to also cause some vulvar and vaginal cancers, but the percentages are not well defined.

FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts
The U.S. Food and Drug Administration today approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding.

FDA to Post Quarterly Report of Potential Safety Issues
The U.S. Food and Drug Administration announced today that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS).

FDA Issues Draft Guidance on Regulating Genetically Engineered Animals
The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals.

Drug Shortages: Current Drug Shortages; Ultra-TechneKow DTE (Technetium Tc 99m Generator) NDA 17-243 (updated)
Updated letter on this current drug shortage

Preventing Medical Errors: Mixups between Insulin U-100 and U-500 (April 2008)
This story originally aired in April 2008. In this special edition of FDA PSN, we are repeating some of the most important safety issues that continue to pose a public health concern. The Institute for Safe Medication Practices (ISMP) recently des...

Drug Shortages: Current Drug Shortages; Methadone Hydrochloride Injection
See Web site for additional information on this current drug shortage

 

Irradiation: A Safe Measure for Safer Iceberg Lettuce and Spinach


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.

Fresh from the Deli American Sub Sandwich Recalled by Landshire, Inc. Because of Possible Health Risk (August 28)
Landshire, Inc. is recalling its American Sub sandwich because it has the potential to be contaminated with Listeria Monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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.

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.

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.

 

FDA needs more time on Lilly, Daiichi anti-clot drug - Forbes


FDA needs more time on Lilly, Daiichi anti-clot drug - Forbes
NEW YORK (Reuters) - Eli Lilly and Co (nyse: LLY - news - people ) and Daiichi Sankyo Co Ltd said Friday that U.S. health regulators have not completed a review of their closely watched anti-clotting drug prasugrel, leaving the drug's fate in limbo
Source: www.forbes.com

FDA says changes coming in wake of critical report - San Francisco Gate
The nation's fresh produce would be safer if U.S. farmers were required to adopt strict standards for growing leafy greens similar to industry-written ones devised for California growers, a Food and Drug Administration official said Friday. Dr. David
Source: www.sfgate.com

FDA issues warning on Chinese coffees, candy - Chicago Tribune
WASHINGTON—The powdered milk contamination scare that has killed four Chinese infants and sickened 53,000 more reached American shores Friday when the Food and Drug Administration recommended that consumers avoid a line of coffees and a candy made
Source: www.chicagotribune.com

Anemia Drugs Linked to Stroke Study Deaths: FDA - KVIA.com
FRIDAY, Sept. 26 (HealthDay News) -- Preliminary results from a German study suggest that stroke patients' use of anti-anemia drugs such as Aranesp, Procrit and Epogen might end up boosting their risk for death, the U.S. Food and Drug Administration
Source: www.kvia.com

Indevus shares double on deals with FDA, Teva - CNN Money
NEW YORK (Associated Press) - Shares of Indevus Pharmaceuticals Inc. more than doubled Friday after the company said it is collaborating with Teva Pharmaceutical Industries Ltd. to develop a treatment for stuttering and could move forward with its
Source: money.cnn.com

In wake of critical report FDA says changes coming - San Diego Union-Tribune
FRESNO – The nation's fresh produce would be safer if U.S. farmers were required to adopt strict standards for growing leafy greens similar to industry-written ones devised for California growers, a Food and Drug Administration official said Friday
Source: www.signonsandiego.com

 

Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated


Drug Shortages: Drugs to be Discontinued; Cefotan (cefotetan injection)- updated
See additional information in Related Information section.

Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection) - updated
See information in Related Information section.

 

FDA Updates Health Information Advisory on Melamine Contamination


FDA Updates Health Information Advisory on Melamine Contamination
The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine.

Allergy Alert on Undeclared Dairy in Margaritaville Island Lime Tortilla Chips (September 12)
El Matador Enterprises, makers of Margaritaville Tortilla Chips is voluntarily recalling 13-ounce bags of Margaritaville Island Lime Tortilla Chips because they may contain undeclared whey in the spice blend.

Voluntary Recall: Wegmans In-Store Made Bagels (September 10)
Wegmans Food Markets, Inc. is voluntarily recalling all varieties of its in-store made bagels and bialys (flattened bagels with various toppings, i.e. pizza) sold in the bakery and purchased between August 24 and September 9, 2008. This recall is being initiated because the bagels may contain pieces of a metal spring from a mixer that entered the dough, which is produced at Wegmans' Central Bakeshop in Rochester, posing a possible choking hazard.

Sprouters Northwest, Inc. Recalls Alfalfa Sprout Products Because of Possible Health Concern (September 5)
Sprouters Northwest, Inc. of Kent, Washington is recalling its alfalfa sprout products (alfalfa sprouts, onion sprouts, and salad sprouts) because they may be linked to a recent outbreak of Salmonellosis in Oregon and Washington State. To date, 13 cases of Salmonella Typhimirium infection have been associated with the consumption of raw alfalfa sprouts.

The Hershey Company Announces Nationwide Voluntary Recall of Hershey's Chocolate Shell Topping Due to Undeclared Almonds (September 4)
The only 7.25-ounce bottles of Hershey's Chocolate Shell Topping affected have the code 69N printed on the back of the bottle below the UPC symbol. The UPC/Bar Code is 346000. The item in question was available for purchase nationwide after July 8, 2008.

FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures
The U.S. Food and Drug Administration today announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications.

Fresh from the Deli American Sub Sandwich Recalled by Landshire, Inc. Because of Possible Health Risk (August 28)
Landshire, Inc. is recalling its American Sub sandwich because it has the potential to be contaminated with Listeria Monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Lucky Country Inc. Recalls All Natural Black Licorice Products (September 5)
Lucky Country Inc. of Lincolnton, NC is recalling all of its natural black licorice products from California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Massachusetts, Minnesota, New Hampshire, Pennsylvania, Utah, Virginia, and Washington State due to elevated levels of lead.

FDA to Post Quarterly Report of Potential Safety Issues
The U.S. Food and Drug Administration announced today that it has posted on its Web site its first quarterly report that lists certain drugs that are being evaluated for potential safety issues. The drugs have been identified based on a review of reports in FDA's Adverse Event Reporting System (AERS).

 

FDA Blamed For Ineffective Produce Testing - Redorbit.com


FDA Blamed For Ineffective Produce Testing - Redorbit.com
The U.S. Food and Drug Administration have addressed concerns for another salmonella outbreak, after recurring attacks of food poisoning, with continued work. The FDA wants to improve the quality and safety of fresh produce, a report released on
Source: www.redorbit.com

F.D.A. Reviewing Deaths in Anemia Drug Study - Gadsden Times
Sixteen percent of patients who were treated with the drug, Eprex, had died three months after the study began, compared with 9 percent who were given a placebo, the Food and Drug Administration said in a statement.
Source: www.gadsdentimes.com

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