December 13, 2008
 

Mercury-tainted fish on FDA menu - Chicago Tribune


Mercury-tainted fish on FDA menu - Chicago Tribune
In the waning days of the Bush presidency, the Food and Drug Administration is pushing to scuttle the government's advice about mercury-contaminated seafood, a dramatic policy change that would, in effect, encourage women and children to eat more
Source: www.chicagotribune.com

FDA Retracts Previous Consumer Advice Over Mercury In Fish - Redorbit.com
The federal government has, for many years, recommended that pregnant women and young children limit their consumption of fish to avoid exposure to potentially harmful amounts of mercury. But there’s now an ongoing debate between two top consumer
Source: www.redorbit.com

Schering-Plough hepatitis C drug approved for kids - Courier-Post
TRENTON — The first high-tech, long-acting treatment for hepatitis C in children, a two-drug combination from Schering-Plough Corp., has been approved by the Food and Drug Administration. Schering-Plough said Friday the FDA had approved sales of a
Source: www.courierpostonline.com

FDA Requires Safety Measures For Oral Sodium Phosphate Products - eMaxHealth.com
Today, the U.S. Food and Drug Administration announced that it will add a Boxed Warning to the prescription oral sodium phosphate products Visicol and OsmoPrep to warn consumers about the risk of acute phosphate nephropathy (a type of acute kidney
Source: www.emaxhealth.com

FDA Sets Safety Level for Baby Formula - AOL
WASHINGTON (Nov. 28) - Federal regulators set a safety threshold Friday for the industrial chemical melamine that is greater than the amount of contamination found so far in U.S.-made infant formula. Food and Drug Administration officials set a
Source: news.aol.com

Asthma Drugs Safe? FDA Wants Outside Help - ClickOnDetroit.com
WASHNGTON -- Deadlocked over the risks of long-acting asthma drugs, government health officials Wednesday asked outside advisers if four medications used by millions of patients should remain on the market. An unusually large panel of some 30 medical
Source: www.clickondetroit.com

FDA: Asthma drugs pose increased risks - Philiy.com
The Food and Drug Administration said yesterday that three popular asthma medicines may increase risks of hospitalization and death in some asthma patients. The safety of the drugs - Serevent, manufactured by GlaxoSmithKline P.L.C.; Symbicort, made
Source: www.philly.com

More treatment may help small breast tumors - San Francisco Gate
Saturday, December 13, 2008 Some women with small breast tumors may have a greater risk of the cancer recurring after treatment than has been believed, and might benefit from taking the drug Herceptin, a new study suggests. Treatments like
Source: www.sfgate.com

 

Healon D Ophthalmic Viscosurgical Device


Healon D Ophthalmic Viscosurgical Device
Recall of one lot of the product because some of the tested OVD syringes had endotoxin levels above the required limit.

FDA Acts to Reduce Risk of Salmonella Infections
Find out why pet turtles may be a health risk and how FDA is enforcing a ban on the small creatures.

Some Medications and Driving Don't Mix
Some prescription and over-the-counter (OTC) medicines can cause reactions that may make it unsafe to drive.

 

FDA advisers: restrict some asthma drugs - WTOP Radio


FDA advisers: restrict some asthma drugs - WTOP Radio
WASHINGTON (AP) - FDA advisers say some long-acting asthma drugs are too risky. Medical and scientific advisers to the Food and Drug Administration on Thursday recommended that Foradil and Serevent no longer be used for asthma. But they spared Advair
Source: www.wtopnews.com

FDA Reconsiders Consumer Advice On Fish - WBZ-TV
WASHINGTON (AP) ― The federal government has been saying for years that pregnant women and young children should limit their consumption of fish to avoid exposure to potentially harmful amounts of mercury. But now, two top consumer protection
Source: wbztv.com

FDA reconsiders consumer advice on fish - KTIV
WASHINGTON (AP) - The federal government has been saying for years that pregnant women and young children should limit their consumption of fish to avoid exposure to potentially harmful amounts of mercury. But now, two top consumer protection
Source: www.ktiv.com

FDA, EPA at odds on consumer warnings about fish - Boston Globe
WASHINGTON - For years, the federal government has recommended that pregnant women and young children limit their consumption of fish to avoid exposure to potentially harmful amounts of mercury. Now, two top consumer protection agencies are at odds
Source: www.boston.com

FDA Warns Against Bowel Cleansing Drugs for Colonoscopy - eMaxHealth.com
Bowel cleansing products that contain sodium phosphate have received a stern warning from the FDA about the potential of the products to cause acute kidney damage. Two products available by prescription, Visicol and OsmoPrep have received "black box
Source: www.emaxhealth.com

Hepatitis C treatment for children wins FDA approval - Providence Journal
TRENTON, N.J. — The first high-tech, long-acting treatment for hepatitis C in children, a two-drug combination from Schering-Plough Corp., has been approved by the Food and Drug Administration. Schering-Plough said yesterday that the FDA had
Source: www.projo.com

FDA OKs children's hepatitis C drug - Raleigh News & Observer
Story Tools TRENTON, N.J. - The first high-tech, long-acting treatment for hepatitis C in children, a two-drug combination from Schering-Plough Corp., has been approved by the Food and Drug Administration. Schering-Plough said Friday that the FDA had
Source: www.newsobserver.com

US FDA advisers back new female condom - Antara Interactive
Gaithersburg,Md., (ANTARA News/ Reuters) - A potentially less-costly version of Female Health Co's condom for women won unanimous backing from a U.S. Food and Drug Administration advisory panel on Thursday. A lower price could attract more users and
Source: www.antara.co.id


December 12, 2008
 

Advair cleared as asthma drug, two others not okay [video] - Gaysocialites.com


Advair cleared as asthma drug, two others not okay [video] - Gaysocialites.com
When it comes to asthma drugs, the Food and Drug Administration has decided that Advair and Symbicort are safe. Others, however, are not. The FDA says patients need to take an asthma medication that has a steriod included. That doesn't mean you have
Source: gaysocialites.com

FDA Warns Against Bowel Cleansing Drugs for Colonoscopy - eMaxHealth.com
Bowel cleansing products that contain sodium phosphate have received a stern warning from the FDA about the potential of the products to cause acute kidney damage. Two products available by prescription, Visicol and OsmoPrep have received "black box
Source: www.emaxhealth.com

 

Barr's BLA for Adenovirus Type 4 and 7 Live Oral Vaccines Accepted for - Biloxi Sun Herald


Barr's BLA for Adenovirus Type 4 and 7 Live Oral Vaccines Accepted for - Biloxi Sun Herald
MONTVALE, N.J., Dec. 11 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Duramed Pharmaceuticals, Inc.'s Adenovirus Types 4 and 7 Live Oral
Source: www.sunherald.com

FDA Draft Report Urges Consumption of Fish, Despite Mercury - Washington Post
The Food and Drug Administration is urging the government to amend its advisory that women and children should limit how much fish they eat, saying that the benefits of seafood outweigh the health risks and that most people should eat more fish, even
Source: www.washingtonpost.com

FDA Rethinks Warning on Fish - Washington Post
The Food and Drug Administration is urging the government to amend its advisory that women and children should limit how much fish they eat, saying that the benefits of seafood outweigh the health risks and that most people should eat more fish, even
Source: www.washingtonpost.com

FDA accepts application for Merck HIV drug - CNN Money
NEW YORK (Associated Press) - Drugmaker Merck & Co. said Friday the U.S. Food and Drug Administration has accepted its supplemental new drug application for the HIV drug Isentress. The company wants approval to market the drug for use with other
Source: money.cnn.com

FDA panel: Two asthma drugs risky but Advair OK - HealthCentral.com
ROCKVILLE, Maryland (Reuters) - GlaxoSmithKline Plc's widely prescribed drug Advair is safe enough for treating asthma but two lesser-used medicines are too risky, a U.S. advisory panel ruled on Thursday. Evidence of asthma-related deaths and serious
Source: www.healthcentral.com

 

Avoiding Drug Interactions


Avoiding Drug Interactions
Be careful about the three main types of interactions: drugs with food and beverages, drugs with dietary supplements, and drugs with other drugs.

FDA Acts to Reduce Risk of Salmonella Infections
Find out why pet turtles may be a health risk and how FDA is enforcing a ban on the small creatures.

Preventing Medical Errors: Recognizing Warfarin Brand Names
A recent report by the Institute for Safe Medication Practices (ISMP) notes that some health professionals and patients may not realize that Jantoven is a brand name for the drug warfarin. That could result in inadvertently prescribing and dispensin...

Healon D Ophthalmic Viscosurgical Device
Recall of one lot of the product because some of the tested OVD syringes had endotoxin levels above the required limit.

Recalls and Melamine Contamination
FDA has increased inspections and product testing in response to the melamine contamination problem that originated in Chinese dairy products.

Addressing Questions About Gardasil
FDA addresses the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV)

 

Vaccines Stand Ready for Flu Season


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

Food Safety Tips for Healthy Holidays
FDA gives consumers practical food safety tips to help prevent foodborne illness.

Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection
See Web site for additional information

Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection
See Web site for additional information

Beware of Extortion Scam by FDA Impersonators
As part of a fraudulent scheme to extort money, callers have falsely identified themselves as "FDA special agents" or other FDA officials.

Preventing Medical Errors: Recognizing Warfarin Brand Names
A recent report by the Institute for Safe Medication Practices (ISMP) notes that some health professionals and patients may not realize that Jantoven is a brand name for the drug warfarin. That could result in inadvertently prescribing and dispensin...

Drug Shortages: Current Drug Shortages; Alprostadil 0.5 mg/mL injection
Alprostadil 0.5 mg/mL injection: Teva Pharmaceuticals: Manufacturing delays; Bedford: Manufacturing delays; Pfizer, Inc.- Prostin VR pediatric Injection available from Pfizer

 

US FDA Advisers Back New Female Condom - Javno


US FDA Advisers Back New Female Condom - Javno
A lower price could attract more users and allow health organizations to distribute more of the condoms to help stem the spread of the virus that causes AIDS, the panel heard. The new version is also quieter, with panelists saying the new, softer
Source: www.javno.com

Medtronic to report patient death to FDA: report - Reuters
(Reuters) - Medtronic Inc (MDT.N: Quote , Profile , Research , Stock Buzz ) will report to the Food and Drug Administration (FDA) the death of a patient who underwent surgery with one of its products, the Wall Street Journal said, citing the
Source: www.reuters.com

Barr says FDA is reviewing biotech vaccines - Boston Globe
MONTVALE, N.J.— Barr Pharmaceuticals Inc. said Thursday the Food and Drug Administration is reviewing applications for the company's first two biologic drug candidates, which are designed to treat two strains of a common cold virus. The two vaccine
Source: www.boston.com

Mississippi residents sue over Katrina housing funds - Meridian Star
JACKSON (AP) — Housing advocates and low-income residents sued Wednesday to stop Mississippi from spending a half-billion federal dollars to expand a damaged port rather than replace homes destroyed by Hurricane Katrina. The Mississippi State
Source: www.meridianstar.com

FDA: Colonoscopy preparation drug could harm kidneys - Newsday
Drugs to clear the bowels before a colonoscopy may harm the kidneys, according to U.S. regulators, who ordered new warnings on prescription versions of the products made by Salix Pharmaceuticals Ltd. Oral sodium phosphate drugs, sold with and without
Source: www.newsday.com

Wrinkle Fillers Need Better Label Warnings: FDA Panel - Atlanta Journal Constitution
TUESDAY, Nov. 18 (HealthDay News) -- American women who turn to cosmetic treatments called dermal fillers to ease wrinkles must be better informed about the health risks these products pose, an advisory panel to the U.S. Food and Drug Administration
Source: www.ajc.com

Critics Top Shortlist for FDA Head - Wall Street Journal
WASHINGTON -- A doctor who once denounced Pfizer Inc. for holding a marketing event in a pool hall is leading President-elect Barack Obama's team formally assessing the troubled Food and Drug Administration, boosting his chances of becoming the next
Source: online.wsj.com

FDA Touts Efforts to Enhance Food Safety - Atlanta Journal Constitution
MONDAY, Dec. 1 (HealthDay News) -- Responding to criticism that it has done a poor job safeguarding the nation's food supply, the U.S. Food and Drug Administration released a report Monday detailing its efforts to protect consumers. Among the most
Source: www.ajc.com

 

FDA to add stern colonoscopy-drug warning - Arizona Daily Star


FDA to add stern colonoscopy-drug warning - Arizona Daily Star
WASHINGTON — Federal health officials said Thursday that they will add the sternest safety warnings available to drugs used before colonoscopies, following reports of kidney damage in several patients. The Food and Drug Administration said it has
Source: www.azstarnet.com

FDA Urges Fish Consumption, Despite Mercury Contamination - Washington Post
The Food and Drug Administration is urging the government to amend its advisory that women and children should limit how much fish they eat, saying that the benefits of seafood outweigh the health risks and that most people should eat more fish, even
Source: www.washingtonpost.com

FDA advisers back limits on asthma drugs - Baltimore Sun
WASHINGTON Government health advisers recommended restrictions yesterday on some long-acting asthma drugs, although not Advair, a top-selling medication. Outside experts advising the Food and Drug Administration said Foradil and Serevent no longer
Source: www.baltimoresun.com

FDA: Colonoscopy preparation drug could harm kidneys - Newsday
Drugs to clear the bowels before a colonoscopy may harm the kidneys, according to U.S. regulators, who ordered new warnings on prescription versions of the products made by Salix Pharmaceuticals Ltd. Oral sodium phosphate drugs, sold with and without
Source: www.newsday.com

FDA advisers vote for ban on 2 drugs to treat asthma - Seattle Times
ROCKVILLE, Md. — A panel of federal drug experts voted Thursday to recommend the drugs Serevent and Foradil be banned for the treatment of asthma, but the experts said Advair and Symbicort should continue to be used. The experts, gathered by the
Source: seattletimes.nwsource.com

Critics Top Shortlist for FDA Head - Wall Street Journal
WASHINGTON -- A doctor who once denounced Pfizer Inc. for holding a marketing event in a pool hall is leading President-elect Barack Obama's team formally assessing the troubled Food and Drug Administration, boosting his chances of becoming the next
Source: online.wsj.com

FDA puts black box warning on bowel-clearing drugs - Arlington Heights Daily Herald
WASHINGTON -- Federal health officials said Thursday they will add the sternest safety warnings available to drugs used before colonoscopies, following reports of kidney damage in several patients. The Food and Drug Administration said it has
Source: www.dailyherald.com

FDA to add 'black-box' warnings to bowel-cleansing drugs - Boston Globe
WASHINGTON - Federal health officials said yesterday that they will add the sternest safety warnings available to prescription drugs used before colonoscopies, following reports of kidney damage in several patients. The Food and Drug Administration
Source: www.boston.com

December 11, 2008
 

Acusphere, Inc.’s Stock Trading Halted Today; FDA Advisory Committee - Earthtimes


Acusphere, Inc.’s Stock Trading Halted Today; FDA Advisory Committee - Earthtimes
WATERTOWN, Mass. - (Business Wire) Acusphere, Inc. (NASDAQ: ACUS) today announced that NASDAQ has halted trading in the Company’s common stock today. The Cardio Renal Advisory Committee to the U.S. Food & Drug Administration is meeting, in a public
Source: www.earthtimes.org

BioSense builds bedside drug tester - Mass High Tech
Woburn-based biotech startup BioSense Technologies Inc. is looking for cash and partners to take its infectious disease diagnostic technology right to the patient’s bedside. The company has developed its Z-Sense biological detection platform, a
Source: www.masshightech.com

 

Pain Therapeutics Receives Complete Response Letter From FDA for - Yahoo Finance


Pain Therapeutics Receives Complete Response Letter From FDA for - Yahoo Finance
CUPERTINO, Calif., Dec. 11 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX - News ) today reported that Pain Therapeutics, Inc. (Nasdaq: PTIE - News ) has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA
Source: biz.yahoo.com

FDA seeks more info on painkiller candidate Remoxy - CNBC
NEW YORK - Regulators delayed a decision on the painkiller Remoxy by requesting more data on the drug candidate, a move that sent shares of developer Pain Therapeutics Inc. tumbling to a three-year low. Pain Therapeutics said the Food and Drug
Source: www.cnbc.com

Barr says FDA is reviewing biotech vaccines - Forbes
Barr Pharmaceuticals Inc. said Thursday the Food and Drug Administration is reviewing applications for the company's first two biologic drug candidates, which are designed to treat two strains of a common cold virus. The two vaccine pills are
Source: www.forbes.com

FDA To Review New Female Condom - eMaxHealth.com
An FDA advisory panel this week is scheduled to review a new and possibly less expensive version of the female condom for its efficacy in preventing pregnancies, HIV and other sexually transmitted infections, Reuters India reports. The Female Health
Source: www.emaxhealth.com

 

Lilly Highlights Transformation Strategy for Wall Street, Reviews - Yahoo Finance


Lilly Highlights Transformation Strategy for Wall Street, Reviews - Yahoo Finance
NEW YORK, Dec. 11 /PRNewswire-FirstCall/ -- -- Innovation and Patient-Centered Approach Expected to Drive Future Success -- Lilly Climbs into Top 10 Pharmaceutical Companies in Worldwide Sales and Is Fastest Growing in U.S. -- FIPNet Strategy Expands
Source: biz.yahoo.com

Levoleucovorin (FUSILEV™) Listed in the NCCN Drugs & Biologics - Businesswire.com
IRVINE, Calif.--( BUSINESS WIRE )--Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI) today announced the listing of FUSILEV™ (levoleucovorin) for injection in the National Comprehensive Cancer Network ® (NCCN) Drugs and Biologic Compendium™ to be
Source: www.businesswire.com

Abaxis Point-of-Care Test Panels Gain FDA CLIA-Waived Status - Earthtimes
Author : Abaxis, Inc. UNION CITY, Calif. , Dec. 11 /PRNewswire-FirstCall/ -- Abaxis, Inc. (Nasdaq: ABAX), a medical products company manufacturing point-of-care blood analysis systems, today announced that the U.S. Food and Drug Administration (FDA
Source: www.earthtimes.org

Plans for Exenatide Once Weekly NDA Submission by End of First Half of - Biloxi Sun Herald
SAN DIEGO, INDIANAPOLIS, and CAMBRIDGE, Mass., Dec. 11 /PRNewswire/ -- Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA
Source: www.sunherald.com

 

Dallas-based ACS awarded contract by the U.S. Food and Drug - Pegasus News


Dallas-based ACS awarded contract by the U.S. Food and Drug - Pegasus News
DALLAS — Affiliated Computer Services, Inc. today announced that it has been selected as a subcontractor to support the U.S. Food and Drug Administration's (FDA) Information and Computer Technologies for the 21st Century (ICT21) initiative
Source: www.pegasusnews.com

Drugmakers to make clear actors in advertising - Reuters
WASHINGTON (Reuters) - The drug industry is taking more voluntary steps to make its consumer marketing more straightforward, including making it clear when actors are used in commercials and other advertisements, the leading industry lobby group said
Source: www.reuters.com

FDA deadlocked on asthma drug risks - Washington Post
WASHINGTON -- Government health officials Wednesday publicly aired deep differences over the safety of long-acting asthma drugs and called on outside medical and scientific advisers to help settle the issue. Experts from the Food and Drug
Source: www.washingtonpost.com

Advisory Panel Weighs Conflict on Asthma Drugs - Star News Online
Dr. David Graham, a safety official in the Food and Drug Administration, strongly recommended that the drugs, Advair, Symbicort, Serevent and Foradil, no longer be used to treat asthma in adults or children because they provide few benefits over
Source: www.starnewsonline.com

FruitFast® Offers Year-End Discount on All-Natural Products -- Looks - PR.com
FruitFast® makes whole fruit goodness available year-round. FruitFast is offering a 10% discount on all product orders during December. Traverse City, MI, December 11, 2008 --( PR.com )-- Brownwood Acres/ FruitFast®, a fruit supplement company
Source: www.pr.com

Acusphere Announces Results of FDA Advisory Committee Meeting - Earthtimes
WATERTOWN, Mass. - (Business Wire) Acusphere, Inc. (NASDAQ: ACUS) today announced that the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration advised that the diagnostic benefit of contrast enhancement using
Source: www.earthtimes.org

Testing Sought in Enhanced Defibrillator - Wall Street Journal
Two prominent heart doctors who helped disclose previous medical-device defects now are urging the heart-defibrillator industry and the Food and Drug Administration to conduct human studies before putting an important new technology into the devices
Source: online.wsj.com

MoH takes over food safety supervision role from SFDA - Interfax Information Agency China
Shanghai. December 11. INTERFAX-CHINA - The Ministry of Health (MoH) has taken over food safety management and inspection functions previously held by the State Food and Drug Administration (SFDA), a MoH spokesman announced at a media conference on
Source: www.interfax.cn

December 10, 2008
 

FDA panel pans Acusphere heart-imaging drug - WTOP Radio


FDA panel pans Acusphere heart-imaging drug - WTOP Radio
WASHINGTON (AP) - Federal advisers said Wednesday the risks of an imaging drug made by Acusphere, including abnormally low blood pressure, outweigh any advantages it has over older products. The Food and Drug Administration 's panel of heart drug
Source: www.wtopnews.com

U.S. FDA panel hears risks with asthma drug - Guardian Unlimited
ROCKVILLE, Md., Dec 10 (Reuters) - U.S. drug reviewers publicly clashed on Wednesday over how to handle a higher risk of death and serious complications seen with a class of asthma medicines now used by millions of patients including children. The
Source: www.guardian.co.uk

Acusphere Announces Results of FDA Advisory Committee Meeting - PR Inside
Acusphere, Inc. (NASDAQ: ACUS) today announced that the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration advised that the diagnostic benefit of contrast enhancement using Acusphere"s ImagifyTM (Perflubutane
Source: www.pr-inside.com

FDA deadlocked on asthma drug risks - Associated Press
WASHINGTON (AP) -- Deadlocked over the risks of long-acting asthma drugs, government health officials Wednesday asked outside advisers if four medications used by millions of patients should remain on the market. An unusually large panel of some 30
Source: hosted.ap.org

FDA Advisers Weigh Asthma Drugs Risks - CBS 2 KCAL 9
WASHINGTON (AP) ― Government health officials Wednesday publicly aired deep differences over the safety of long-acting asthma drugs and called on outside medical and scientific advisers to help settle the issue. Experts from the Food and Drug
Source: cbs2.com

FDA deadlocked on asthma drug risks - Washington Post
WASHINGTON -- Government health officials Wednesday publicly aired deep differences over the safety of long-acting asthma drugs and called on outside medical and scientific advisers to help settle the issue. Experts from the Food and Drug
Source: www.washingtonpost.com

Acusphere Announces Results of FDA Advisory Committee Meeting - Earthtimes
WATERTOWN, Mass. - (Business Wire) Acusphere, Inc. (NASDAQ: ACUS) today announced that the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration advised that the diagnostic benefit of contrast enhancement using
Source: www.earthtimes.org

UPDATE 2-US FDA panel rejects Acusphere heart imaging agent - Reuters
SILVER SPRING, Md., Dec 10 (Reuters) - A U.S. Food and Drug Administration advisory panel rejected Acusphere Inc's (ACUS.O: Quote , Profile , Research , Stock Buzz ) imaging contrast agent on Wednesday, saying possible risks outweighed its potential
Source: www.reuters.com

FDA Advisory Committee Unanimously Recommends Approval of Genzyme?s - PR Inside
www.genzyme.com - Genzyme Corporation (Nasdaq: GENZ) today announced that the FDA"s Orthopaedic and Rehabilitation Devices Advisory Committee voted unanimously (5 " 0) in favor of approval without conditions of Synvisc-One" (hylan G-F 20). The
Source: www.pr-inside.com

 

FDA panel pans Acusphere heart-imaging drug - WTOP Radio


FDA panel pans Acusphere heart-imaging drug - WTOP Radio
WASHINGTON (AP) - Federal advisers said Wednesday the risks of an imaging drug made by Acusphere, including abnormally low blood pressure, outweigh any advantages it has over older products. The Food and Drug Administration 's panel of heart drug
Source: www.wtopnews.com

FDA deadlocked on asthma drug risks - Washington Post
WASHINGTON -- Government health officials Wednesday publicly aired deep differences over the safety of long-acting asthma drugs and called on outside medical and scientific advisers to help settle the issue. Experts from the Food and Drug
Source: www.washingtonpost.com

Acusphere Announces Results of FDA Advisory Committee Meeting - Earthtimes
WATERTOWN, Mass. - (Business Wire) Acusphere, Inc. (NASDAQ: ACUS) today announced that the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration advised that the diagnostic benefit of contrast enhancement using
Source: www.earthtimes.org

FDA Issues Complete Response Letter for Oritavancin - PR Inside
www.targanta.com - Targanta Therapeutics Corporation (Nasdaq: TARG) announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for oritavancin for the
Source: www.pr-inside.com

UPDATE: Panel Says Acusphere Drug Benefits Inconsistent - CNN Money
SILVER SPRING, Md. -(Dow Jones)- The benefits associated with Acusphere Inc.'s (ACUS) ultrasound heart-imaging agent are inconsistent and some of the risk signals are disturbing, a group of medical experts said Wednesday. Acusphere, a specialty
Source: money.cnn.com

China names and shames fake drug Web sites - MSNBC
BEIJING - China, beset by food and drug safety scandals, has blacklisted dozens of Web sites for making false claims about traditional Chinese medicine, state media said on Wednesday. The health scares, including the addition of melamine, used in
Source: www.msnbc.msn.com

U.S. FDA panel hears risks with asthma drug - Guardian Unlimited
Food and Drug Administration staff who monitor drugs after approval told an advisory panel they felt none of the medicines known as long-acting beta-agonists (LABAs) should be given to children with asthma. They also urged revoking approval of two
Source: www.guardian.co.uk

FDA Denies ‘Palm Pistol’ Medical Device Coverage - Redorbit.com
The world's first prescription pistol was denied registration on Monday by the Food and Drug Administration. The single-bullet Palm Pistol set the Internet abuzz with speculation that Medicare might even pay for the elderly and disabled to pack heat
Source: www.redorbit.com

Salix acquires license to diarrhea drug for people with HIV - Triangle Business Journal
Shares of Salix rise on good drug news Triangle braces for business and philanthropic impact Napo Pharmaceuticals in $5M license agreement with Salix Dow drops below 10,000; Triangle stocks hit hard The State of Morrisville: Corporations embrace town
Source: triangle.bizjournals.com

FDA panel backs Allergan's eyelash enhancing drug - Associated Press
WASHINGTON (AP) -- A panel of government experts said Friday a glaucoma drug from Allergan appears to be a safe and effective way to make eyelashes longer and fuller. Allergan, which makes Botox anti-wrinkle injections, has asked the Food and Drug
Source: hosted.ap.org

 

Napo Pharmaceuticals Announces License of Crofelemer to Salix - PR Newswire


Napo Pharmaceuticals Announces License of Crofelemer to Salix - PR Newswire
SAN FRANCISCO, Dec. 10 /PRNewswire/ -- Napo Pharmaceuticals, Inc. ("Napo") is pleased to announce a collaboration with Salix Pharmaceuticals, Inc. ("Salix") for the license of crofelemer for all indications in North America, Europe (excluding certain
Source: sev.prnewswire.com

FDA deadlocked on asthma drug risks - Washington Post
WASHINGTON -- Government health officials Wednesday publicly aired deep differences over the safety of long-acting asthma drugs and called on outside medical and scientific advisers to help settle the issue. Experts from the Food and Drug
Source: www.washingtonpost.com

FDA advisers weigh risks of asthma drugs - ABC 33/40 News
Washington - In recent years, millions of asthma patients have started using long-acting drugs to help them breathe more normally, allowing for nights of uninterrupted sleep or workouts at the gym. Now the Food and Drug Administration is
Source: www.abc3340.com

FDA panel pans Acusphere heart-imaging drug - WTOP Radio
WASHINGTON (AP) - Federal advisers said Wednesday the risks of an imaging drug made by Acusphere, including abnormally low blood pressure, outweigh any advantages it has over older products. The Food and Drug Administration 's panel of heart drug
Source: www.wtopnews.com

FDA Advisory Committee To Discuss Genzyme's Synvisc-One PMA On Tuesday - Medical News Today
Genzyme Corporation (Nasdaq: GENZ) today announced that its Premarket Approval (PMA) application supplement for Synvisc-One™ (hylan G-F 20) will be discussed this Tuesday, December 9th, at a public meeting of the FDA's Orthopaedic and
Source: www.medicalnewstoday.com

 

FDA Grants NeoVista's Request to Utilize Novel Wet AMD Treatment in - PR Newswire


FDA Grants NeoVista's Request to Utilize Novel Wet AMD Treatment in - PR Newswire
FREMONT, Calif., Dec. 10 /PRNewswire/ -- NeoVista, Inc., announced today that the U.S. Food and Drug Administration (FDA) had approved the company's "compassionate case" waiver to utilize its novel wet age-related macular degeneration (AMD) treatment
Source: sev.prnewswire.com

FDA Advisers Weigh Asthma Drugs Risks - WBZ-TV
WASHINGTON (AP) ― Government health officials Wednesday publicly aired deep differences over the safety of long-acting asthma drugs and called on outside medical and scientific advisers to help settle the issue. Experts from the Food and Drug
Source: wbztv.com

Rep. Barton Questions FDA Delay In Blood Thinner Seizure - CNN Money
WASHINGTON -(Dow Jones)- Rep. Joe Barton , R-Texas, on Wednesday questioned why the Food and Drug Administration waited six months to seize contaminated lots of a popular blood thinner from an Ohio -based company that wasn't properly recalling the
Source: money.cnn.com

FDA Denies ‘Palm Pistol’ Medical Device Coverage - Redorbit.com
The world's first prescription pistol was denied registration on Monday by the Food and Drug Administration. The single-bullet Palm Pistol set the Internet abuzz with speculation that Medicare might even pay for the elderly and disabled to pack heat
Source: www.redorbit.com

Genzyme Shares Rise on FDA Panel Nod - Street.Com
Genzyme's new osteoarthritis drug received recommendation from Food and Drug Administration panel, giving the company's shares a boost Wednesday. Genzyme's stock was up $2.24, or 3.54%, at $65.50 in at midday. A five-member FDA panel unanimously
Source: www.thestreet.com

Wary FDA, Others Taking Time With Drug Reviews - Street.Com
A number of regulatory review deadlines passed at the agencies without any action taken during the quarter. The FDA in particular has been more cautious in reviewing new drug applications over the last year, following a spate of safety issues with
Source: www.thestreet.com

FDA advisers weigh asthma drug risks - Philiy.com
WASHINGTON - Government health officials Wednesday publicly aired deep differences over the safety of long-acting asthma drugs and called on outside medical and scientific advisers to help settle the issue. Experts from the Food and Drug
Source: www.philly.com

Genzyme Arthritis Drug Nears FDA Approval - Worcester Business Journal
The U.S. Food and Drug Administration's Orthopedic and Rehabilitation Devices Advisory Committee has recommended a Genzyme Corp. osteoarthritis pain reliever for approval. Genzyme, which has significant operations in Central Massachusetts, is seeking
Source: www.wbjournal.com

December 9, 2008
 

FDA Acts to Avoid Shortage and Strengthen the Safety of Sucraid


FDA Acts to Avoid Shortage and Strengthen the Safety of Sucraid
The U.S. Food and Drug Administration today issued an expedited approval of a supplemental application that allows for changes in the manufacturing of Sucraid (sacrosidase) Oral Solution.

Innohep (tinzaparin sodium injection)
Clinical study stopped early because of interim finding of increase in all-cause mortality in patients who received Innohep.

 

Targanta shares plunge on FDA drug rejection - Forbes


Targanta shares plunge on FDA drug rejection - Forbes
Shares of Targanta Therapeutics Corp. plunged Tuesday after the Food and Drug Administration rejected the company's key antibiotic candidate and called for an additional study. The stock fell $1.10, or 48.9 percent, to $1.15 in midday trading. The
Source: www.forbes.com

Drug trial success a boost for Arena - San Diego Union-Tribune
Shares of Arena Pharmaceuticals rose almost 7 percent yesterday after the San Diego company released positive mid-stage trial results of its obesity drug, lorcaserin. People taking the Arena pill experienced significantly more weight loss, at least 5
Source: www.signonsandiego.com

Drug combination stabilizes disease for relapsed multiple myeloma - HULIQ.com
Mayo Clinic researchers have found that a new combination of medications designed to maximize immune functions improved or stabilized multiple myeloma for 76 percent of patients who had relapsed after previous treatment. Interim results of an ongoing
Source: www.huliq.com

 

Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection


Drug Shortages: Resolved Drug Shortages; Zanosar (Streptozocin) 1gm/vial Injection
See Web site for additional information

Drug Shortages: Current Drug Shortages; Vinblastine Sulfate Injection
See Web site for additional information

Drug Shortages: Resolved Drug Shortages; Proglycem (diazoxide) oral suspension
See Web site for additional information

Preventing Medical Errors: Removing Insulin from Cartons
The Institute for Safe Medication Practices warns that storing insulin vials inside their cardboard cartons after the packages have been opened can be a medical emergency waiting to happen. If the vial is accidentally returned to the wrong carton af...

Recalls and Safety Alerts: Filter Ammonul to Remove Particulates
Ucyclyd Pharma is notifying healthcare professionals that particulate matter has been detected in Ammonul Injection. Ammonul is used as an adjunct in treating hyperammonemia in certain patients with urea cycle disorders. The company says that the...

Drug Shortages: Drugs to be Discontinued; Nimotop (nimodipine) capsules
See Web site for additional information

 

Prescription pistol plan backfires as FDA pulls registration - Charleston Daily Mail


Prescription pistol plan backfires as FDA pulls registration - Charleston Daily Mail
WASHINGTON - It could have been the world's first prescription pistol. The single-bullet Palm Pistol set the Internet abuzz with speculation that Medicare might even pay for the elderly and disabled to have a weapon. But Monday the Food and Drug
Source: www.dailymail.com

FDA Approves GlaxoSmithKline Tetanus, Diphtheria, Whooping Cough - MSN MoneyCentral
GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved BOOSTRIX® [Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed (Tdap)] for use in adults 19-64 years of age
Source: news.moneycentral.msn.com

FDA approves C. R. Bard vascular stent - Newark Star-Ledger
The Food and Drug Administration approved marketing of the flexible, self-expanding stent for common or external iliac artery occlusive disease. Marketing will be done by Bard Peripheral Vascular Division, the company said in a statement. A stent is
Source: www.nj.com

FDA cites safety concerns with Acusphere drug - Boston Globe
WASHINGTON— Shares of Acusphere plummeted Monday after federal regulators raised serious safety concerns about an imaging drug the company has touted as a potential blockbuster product. Watertown, Mass.-based Acusphere has asked the Food and Drug
Source: www.boston.com

 

Emphasis on Risk May Scare Patients Away From Treatment - Wall Street Journal


Emphasis on Risk May Scare Patients Away From Treatment - Wall Street Journal
Once in a while, the Health Blog actually reads the list of side effects on a drug’s label before swallowing. The exercise, we find, leads to a lot of worry. Happily, we haven’t ended up experiencing the worst side effects so far. Maybe we’ve
Source: blogs.wsj.com

Merck Outlines Long-Term Prospects and Progress on Strategic Plan at - MSN MoneyCentral
Merck & Co., Inc. today hosted its Annual Business Briefing where it outlined its long-term prospects and announced several key improvements in how the Company develops and markets medicines and vaccines worldwide. The Company will continue to
Source: news.moneycentral.msn.com

 

FDA reports on food supply safety - The Money Times


FDA reports on food supply safety - The Money Times
Washington -- The U.S. Food and Drug Administration issued a report on the year-long implementation of its Food Protection Plan to protect domestic and imported foods. The plan, officials said, outlines strategies for prevention, intervention and
Source: www.themoneytimes.com

FDA nixes proposed ‘prescription pistol’ - MSNBC
WASHINGTON - It could have been the world's first prescription pistol. The single-bullet Palm Pistol set the Internet abuzz with speculation that Medicare might even pay for the elderly and disabled to pack heat. But on Monday the Food and Drug
Source: www.msnbc.msn.com

FDA Touts Efforts to Enhance Food Safety - Atlanta Journal Constitution
MONDAY, Dec. 1 (HealthDay News) -- Responding to criticism that it has done a poor job safeguarding the nation's food supply, the U.S. Food and Drug Administration released a report Monday detailing its efforts to protect consumers. Among the most
Source: www.ajc.com

Facelift on a Botox budget - Miami Herald
TIPS These come from Dr. Leslie Baumann of the University of Miami's Cosmetic Research and Medicine Institute: • Use sunscreen every day. • Consider the use of a retinoid, a class of chemical compounds derived from vitamin A. Retinoids are in the
Source: www.miamiherald.com

FDA Issues Complete Response Letter for Oritavancin - PR Inside
www.targanta.com - Targanta Therapeutics Corporation (Nasdaq: TARG) announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for oritavancin for the
Source: www.pr-inside.com

December 8, 2008
 

FDA Acts to Avoid Shortage and Strengthen the Safety of Sucraid


FDA Acts to Avoid Shortage and Strengthen the Safety of Sucraid
The U.S. Food and Drug Administration today issued an expedited approval of a supplemental application that allows for changes in the manufacturing of Sucraid (sacrosidase) Oral Solution.

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.

 

Freedom from the FDA - Enter Stage Right


Freedom from the FDA - Enter Stage Right
It took the Food and Drug Administration more than a century to grow into a massive, expensive, wasteful, inflexible, ineffective, distant and indifferent bureaucracy. It now violates a founding principle of the practice of medicine: "First, do no
Source: www.enterstageright.com

FDA Reports Progress In Protecting Food Supply - CattleNetwork.com
The U.S. Food and Drug Administration today released a report on its implementation of the Food Protection Plan that was launched a year ago to protect both domestic and imported food from accidental and intentional contamination. The Plan, which
Source: www.cattlenetwork.com

Zevalin Consolidation in Patients With Complete Remission After - Marketwatch
SEATTLE, Dec 08, 2008 /PRNewswire-FirstCall via COMTEX/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that extended follow-up data for the Zevalin(R) ([90Y]-ibritumomab tiuxetan) First-line Indolent (FIT) study presented at
Source: www.marketwatch.com

Medivir: Marketing Authorization Application for Lipsovir(R) now - Marketwatch
Medivir (STO:MVIRB) announced today that the American (FDA) and European regulatory authorities have validated the NDA and Marketing Authorization Application for Lipsovir(R). The authorities will start the review process to evaluate the data
Source: www.marketwatch.com

Leukaemia drug goes forward - Biotech Sweden
The Norwegian biopharmaceutical company Clavis Pharma has announced positive interim clinical phase II results for Elacyt single agent therapy in patients with late stage acute myeloid leukaemia, AML. Elacyt is currently in development in AML both as
Source: biotech.idg.se

FDA: Risks of new asthma drugs vary - Guardian Unlimited
Associated Press Writer= WASHINGTON (AP) — The blockbuster asthma drug Advair does not appear to have an increased risk of serious respiratory complications seen with similar new medicines, federal health officials said Friday. But a less widely
Source: www.guardian.co.uk

FDA reports on food supply safety - United Press International
People who read this also read Produce can harbor food pathogens CDC: Handling food to avoid illness FDA opens offices in China Research may improve food safety WASHINGTON, Dec. 1 (UPI) -- The U.S. Food and Drug Administration issued a report on
Source: www.upi.com

December 7, 2008
 

White Paper Addresses FDA Approval Challenges Facing Combination - Earthtimes


White Paper Addresses FDA Approval Challenges Facing Combination - Earthtimes
AGAWAM, Mass. , Dec. 1 /PRNewswire/ -- Even as the combination products market continues to experience dramatic growth, the approval process facing manufacturers seeking to introduce new medical devices embedded with pharmaceutical or biologics
Source: www.earthtimes.org

FDA sets 'safe' levels for melamine in baby formula - CNN
(CNN) -- After first saying that they could not determine a threshold for the safe amount of certain toxic chemicals in infant formula, Food and Drug Administration officials said Friday that trace amounts are safe. Worries over melamine in infant
Source: www.cnn.com

Novartis malaria drug safe, effective-US FDA staff - Forbes
WASHINGTON (Reuters) - Data show Novartis (nyse: NVS - news - people ) AG's combination malaria drug Coartem appears to work and causes few serious side effects, Food and Drug Administration regulatory staff said in documents released Monday. "The
Source: www.forbes.com

FDA Reports Significant Progress in Protecting the Food Supply - WebWire
The One-Year Summary of Progress under the Food Protection Plan describes FDA’s efforts to build safety in the U.S. and global food systems The U.S. Food and Drug Administration today released a report on its implementation of the Food Protection
Source: www.webwire.com

GSK Reports PROMACTA(R) (eltrombopag) Significantly Increased Platelet - TradingMarkets.com
"PROMACTA is the first approved agent to show that generating platelets can be achieved and maintained with an oral therapy," said Paolo Paoletti, M.D., Senior Vice President of Oncology R&D, GSK. "With the continued emergence of GSK in oncology, we
Source: www.tradingmarkets.com

FDA Sets Melamine Standard For Baby Formula - Redorbit.com
Federal food regulators said they have found a way to set a safety threshold for the industrial chemical melamine in baby formula that allows for higher levels than those found in U.S.-made batches of the product. “A threshold of 1 part per million
Source: www.redorbit.com

FDA says it's making America's food safer--but melamine is OK in - Scientific American
In the wake of melamine and high-profile food poisoning cases, the embattled Food and Drug Administration (FDA) says that it's taking steps to ensure food safety. In a report released today, the FDA says that it's beefing up its inspection staff by
Source: www.sciam.com

 

Allos Therapeutics reveals top line results from pivotal Phase 2 - RTT News


Allos Therapeutics reveals top line results from pivotal Phase 2 - RTT News
(RTTNews) - Allos Therapeutics Inc. (ALTH: News ) on Sunday announced preliminary top line results from PROPEL, the company's pivotal Phase 2 trial of pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma, at the 50th Annual
Source: www.rttnews.com

Early detection key to FDA food safety effort - Boston Globe
After years of being criticized for its response to food-sickness outbreaks and contaminated imports, the Food and Drug Administration is stepping up efforts to convince the public and skeptical lawmakers that it is making progress in overhauling the
Source: www.boston.com

Novartis Malaria Drug Safe, Effective: FDA - Post Chronicle
Data show Novartis AG's combination malaria drug Coartem appears to work and causes few serious side effects, U.S. Food and Drug Administration regulatory staff said in documents released on Monday. "The majority of AEs (adverse events) were of mild
Source: www.postchronicle.com

Pregnancy, Birth and Beyond - HamptonRoads.com
Pregnancy and Childbirth are sensitive subject to most of us. We spend a good part of our day thinking, researching and planning for an event that will change our life. Whether you come to this blog in hopes of exploring your options for childbirth
Source: hamptonroads.com

Editorial: A reminder of risks supplements pose - Minneapolis Star Tribune
The product's cheesy name and its sad-sack "diet queen to the stars" spokeswoman should have immediately clued in Vikings defensive tackles Kevin and Pat Williams that StarCaps weight loss supplements were something to avoid. Instead, the football
Source: www.startribune.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.

Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II Left Ventricular Assist System (October 24)
Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death.

Safety Concerns and Labeling Changes for Psoriasis Drug Raptiva
FDA has received reports of serious infections leading to hospitalizations and deaths in people who use Raptiva.

Mexican Vanilla With Coumarin: No Bargain
Beware of Mexican vanilla that contains coumarin, a toxic substance banned in the United States.

Wegmans Food Markets, Inc. Issues Voluntary Recall on Wegmans Italian Classics Seasoned Tomato Sauce (November 20)
Wegmans Food Markets, Inc. is initiating a voluntary recall of 24 oz. Wegmans Italian Classics Seasoned Tomato Sauce with a "use-by- date of 11/26/08", UPC 77890 79010.

Nestle Withdraws Nestle Farinha Lactea Cereal in the United States (November 3)
Nestle is withdrawing Nestle Farinha Lactea cereal in the United States. Nestle is taking this action as we have learned that the product may contain residual traces of a pesticide not currently approved for use on wheat in the U.S. While the pesticide is approved for use in Brazil and the noted levels are well below Brazilian standards, it is not used on wheat products in the United States and therefore there is no set standard for its presence in cereal. The pesticide is permitted in the United States on grain crops other than wheat.

Johnson and Johnson--Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall Of Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) Non-Staining Due To Possible Metal Fragments (November 7)
Johnson and Johnson -- Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately.

Walgreens Recalls 173 Teddy Bears With Chocolate Bars Sold Since Late September 2008 (December 5)
Walgreens already has instructed stores to stop selling the product, which is specifically described as an approximately 9-inch high Dressy Teddy Bear with 4-oz. Chocolate Bar. The product's UPC number is 047475864485, and the product tag also includes the item number 291332. Walgreens has not received any reports of illness or injury related to this product.

Harry and David Issues Nationwide Allergy Alert on Undeclared Pecans in Harry and David Moose Munch Confection, Milk Chocolate Gingerbread (October 22)
Harry and David, of Medford, Oregon, is voluntarily recalling approximately 400 1 lb. 4 oz. boxes labeled Harry and David Moose Munch Confection, Milk Chocolate Gingerbread because the package may contain a different Moose Munch product which contains pecans not declared on the ingredient statement. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume this product.

 

WHO limits melamine in food, says traces seem safe - Hanford Sentinel


WHO limits melamine in food, says traces seem safe - Hanford Sentinel
GENEVA - The World Health Organization said Friday that tiny traces of the chemical melamine are not harmful in most foods, but it joined the U.S. and EU in setting a strict limit that regulators should impose before pulling products off the shelf
Source: www.hanfordsentinel.com

Lexicon files application for diabetes drug - MSN MoneyCentral
THE WOODLANDS, Texas (AP) - Lexicon Pharmaceuticals Inc. said Monday it has submitted an investigational new drug application to the U.S. Food and Drug Administration for LX4211, a drug candidate to treat type 2 diabetes. The biopharmaceutical
Source: moneycentral.msn.com

 

Early detection key to FDA food safety effort - Boston Globe


Early detection key to FDA food safety effort - Boston Globe
After years of being criticized for its response to food-sickness outbreaks and contaminated imports, the Food and Drug Administration is stepping up efforts to convince the public and skeptical lawmakers that it is making progress in overhauling the
Source: www.boston.com

 

New mad-cow rule poses its own health dangers - Baltimore Sun


New mad-cow rule poses its own health dangers - Baltimore Sun
LITITZ, Pa. - A federal regulation aimed at preventing mad cow disease from getting into the food supply could create health risks of its own: many thousands of cattle carcasses rotting on farms, spreading germs, attracting vermin and polluting the
Source: www.baltimoresun.com

Short Circuits - Louisville Courier-Journal
Fidelity Investments is joining the rush to satisfy investors' growing appetite for news about financial market turmoil. The nation's largest mutual fund company has launched a redesign of its Web site, www.fidelity.com , with a deeper trove of
Source: www.courier-journal.com

 

EU Prohibits Soy Imports From China Due To Melamine Scare - All Headline News


EU Prohibits Soy Imports From China Due To Melamine Scare - All Headline News
Brussels, Belgium (AHN) - Soy-based imports from China intended for babies and young children will no longer be allowed throughout the 27-member European Union. The European Commission banned on Wednesday the entry of all foods that are soy-based
Source: www.allheadlinenews.com

Allos says drug curbs aggressive lymphoma - Finanz Nachrichten
LOS ANGELES, Dec 6 (Reuters) - Allos Therapeutics Inc ( News ) said on Saturday a small, but potentially pivotal, trial of its experimental drug pralatrexate found it helped curb cancer in 27 percent of patients with an aggressive type of lymphoma
Source: www.finanznachrichten.de

UPDATE 2-US panel supports Allergan drug for longer lashes - FXStreet.com
ROCKVILLE, Md., Dec 5 (Reuters) - A prescription eye drug originally used to treat glaucoma is also safe and effective for adults who want the longer, thicker eyelashes, a U.S. advisory panel said on Friday. The drug, by Botox maker Allergan Inc, was
Source: www.fxstreet.com

'FDA special agent' calls are frauds - Baltimore Sun
Beware of an extortion scheme by callers who falsely identify themselves as "FDA special agents" or other FDA officials, according to the U.S. Food and Drug Administration. Several cases have been reported of callers enticing consumers to purchase
Source: www.baltimoresun.com

President-elect Obama pledges to launch public works program as part - Los Angeles Times
Reporting from Washington -- President-elect Barack Obama on Saturday pledged to launch the biggest public works program since the construction of the interstate highway system in the 1950s as part of his plan to create 2.5 million jobs and stem an
Source: www.latimes.com

FDA Sees Asthma Drug Risks - Post Chronicle
U.S. regulators remain concerned about serious risks from a class of asthma drugs and will ask U.S. advisers next week if approval for treating the lung disease should be revoked, documents released on Friday said. Staff in the Food and Drug
Source: www.postchronicle.com

FDA sets melamine standard for baby formula - San Francisco Examiner
» 19 hrs ago: FDA sets melamine standard for baby formula « 1 day ago: FDA sets safe level for infant formula contaminant Chemist Michael Filigenzi demonstrates how vials of liquefied pet food are placed in trays for testing for the industrial
Source: www.examiner.com

Rx: Will doctors be writing firearm prescriptions? - WorldNetDaily
A hand injury? If so, a New Jersey company claims it has invented a firearm just for you and that it has received federal approval to market the 9-mm handgun as a "medical device," perhaps even with its cost reimbursable to seniors by Medicare
Source: www.worldnetdaily.com

Freedom from the FDA - Enter Stage Right
It took the Food and Drug Administration more than a century to grow into a massive, expensive, wasteful, inflexible, ineffective, distant and indifferent bureaucracy. It now violates a founding principle of the practice of medicine: "First, do no
Source: www.enterstageright.com

Med-tech forum's move coup for state - Indianapolis Star
Indiana landed the Medical Technology Leadership Forum last week, besting world-class competition to host the policy organization. It wasn't really a fair fight. Harvard and Dartmouth universities couldn't stack up to Indiana and Purdue universities
Source: www.indystar.com

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