FDA Issues Warning on Counterfeit Surgical Mesh 3/11/2010 5:39:00 PM The U.S. Food and Drug Administration today warned health care providers and consumers about counterfeit surgical mesh being distributed in the United States under the C. R. Bard/Davol brand name. Surgical mesh products are used to reinforce soft tissue where weakness exists.

Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall 3/11/2010 3:45:00 PM Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.

FDA March 11 Update on the Investigation into the Salmonella Montevideo Outbreak 3/11/2010 2:39:00 PM March 11 Update - As part of the Salmonella Montevideo investigation, the Food and Drug Administration has been actively investigating the supply chain of black and red pepper supplied to Daniele International Inc., Pascoag, R.I.

Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures 3/11/2010 11:15:00 AM FDA review of available data have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.

2009 H1N1 Influenza and its Impact on People with Chronic Medical Conditions: Questions and Answers 3/11/2010 10:00:00 AM The January 12, 2010 National Influenza Vaccination Week Webinar featured Dr. Nicole Lurie with the US Department of Health and Human Services; Dr. Anthony Fiore with Centers for Disease Control and Prevention; Dr. Otis Webb Brawley with American Cancer Society; Christine Tobin with American Diabetes Association; and Mary Partridge with the American Lung Association.

Flu Print Materials Available in Arabic, Chinese, French, German, Hmong, Korean, Russian and Vietnamese 3/11/2010 10:00:00 AM This year's flu materials include messaging to address both Seasonal and 2009 H1N1 flu (sometimes called "swine flu") recommendations.

Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall 3/11/2010 9:15:00 AM Incorrect sodium results may be caused by build-up of protein, bacteria, and sample tube additives in the ion selective electrode flow cell.

Low pathogenic avian influenza found in Denmark 3/11/2010 7:41:00 AM
Vetsweb - At a Danish duck farm in Fuglebjerg, Southwest of the island of Sjælland, the presence of low pathogenic avian influenza type H7 has been reported, ...

Abiomed AB5000 Circulatory Support System: Class I Recall 3/10/2010 4:20:00 PM Device computer may shut down without an alarm, which can lead to serious injuries or death.

WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis 3/10/2010 12:50:00 PM Cases of intravascular hemolysis and its complications have been reported in patients treated for immune thrombocytopenic purpura with WinRho.

NIAID Study: Vaccinating Children against Flu Helps Protect Wider Community 3/10/2010 11:00:00 AM Trial Results in Rural Canadians Show Effect of Herd Immunity

CDC and American College Health Association Spring Break Vaccination Letter 3/9/2010 9:00:00 PM Although flu activity has declined in recent weeks, 2009 H1N1 Influenza viruses continue to spread in the United States and abroad, causing illness, hospitalizations and even deaths.

FDA Approves Botox to Treat Spasticity in Flexor Muscles of the Elbow, Wrist and Fingers 3/9/2010 4:42:00 PM The U.S. Food and Drug Administration today approved Botox (onabotulinumtoxin A) to treat spasticity in the flexor muscles of the elbow, wrist, and fingers in adults. Spasticity is common after stroke, traumatic brain injury, or the progression of multiple sclerosis.

Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife, NK, Responder models): Class I Recall 3/8/2010 2:15:00 PM UPDATED 03/08/2010: Recall classified as Class I, expanded list of affected models. Originally posted 02/09/2010

WHO Updates International H1N1 Flu Situation 3/5/2010 9:10:00 PM As of 28 February 2010, worldwide more than 213 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including at least 16455 deaths.

Weekly FluView Map and Surveillance Report for Week Ending Feb 27, 2010 3/5/2010 9:00:00 PM During week 8 (February 21-27, 2010), influenza activity remained at approximately the same levels as last week in the U.S.

FDA Update on the Investigation into the Salmonella Montevideo Outbreak - March 5, 2010 3/5/2010 6:57:00 PM As part of the Salmonella Montevideo investigation, the Food and Drug Administration has been actively investigating the supply chain of black and red pepper supplied to Daniele International Inc., Pascoag, R.I.

Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall 3/5/2010 12:20:00 PM Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.

CDC Estimates of 2009 H1N1 Influenza Cases, Hospitalizations and Deaths in the United States, April 2009 to January 16, 2010 3/4/2010 9:00:00 PM Estimating the number of individual flu cases in the United States is very challenging because many people with flu don't seek medical care and only a small number of those that do seek care are tested.

FDA Investigation Reveals Salmonella Tennessee at Plant that Makes Flavor Enhancers for Food Processors and Other Distributors 3/4/2010 3:26:00 PM The U.S. Food and Drug Administration is actively investigating positive findings of Salmonella Tennessee in hydrolyzed vegetable protein (HVP) manufactured by Basic Food Flavors Inc. in Las Vegas, Nev. HVP is a flavor enhancer used in a wide variety of processed food products such as soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips and dressings. It is often blended with other spices to make seasonings that are used in or on foods. There are no reports of consumer illness associated with this recall. Only HVP manufactured by Basic Food Flavors is involved in this recall.

FDA Approves Name Change for Heartburn Drug Kapidex 3/4/2010 2:32:00 PM The U.S. Food and Drug Administration has approved a name change for the heartburn drug Kapidex Change to Dexilant is part of FDA effort to prevent medication errors(dexlansoprazole) to avoid confusion with two other medications – Casodex and Kadian. Effective in late April 2010, Takeda Pharmaceuticals North America Inc. will market Kapidex under the new name Dexilant.

FDA Warns Consumers in Puerto Rico of Harmful Bacteria in Hand Sanitizers 3/3/2010 5:59:00 PM The U.S. Food and Drug Administration is warning consumers in Puerto Rico that two hand sanitizers – "Bee-Shield Hand Sanitizer” with Aloe Vera (10 fl. oz. or 1 gallon bottles) and “MD Quality Hand Sanitizer” with Aloe Vera (10 fl oz. bottles) – contain high levels of a bacteria, Burkholderia cepacia, that can cause serious infections in humans.

La FDA advierte a los consumidores en Puerto Rico acerca de la presencia de una bacteria dañina en desinfectantes para manos 3/3/2010 5:59:00 PM La Administración de Medicamentos y Alimentos (FDA por sus siglas en inglés) está advirtiendo a los consumidores en Puerto Rico acerca de un alto contenido de la bacteria Burkholderia cepacia en los desinfectantes para manos: "Bee-Shield Hand Sanitizer” con Aloe Vera ( botellas de 10 onzas o de un galón) y “MD Quality Hand Sanitizer” con Aloe Vera (botellas de 10 onzas). La bacteria Burkholderia cepacia puede causar infecciones graves en las personas.

Virus experiment reminds that flu surprises await 3/3/2010 2:52:00 PM
EthiopianReview.com - H5N1 avian influenza is still circulating. It has infected 478 people and killed 286 of them since it re-emerged in Asia in 2003.

Culling and compensation going hand in hand 3/3/2010 2:45:00 PM
KuenselOnline - Bhutan - Nu 115,376 has been paid as compensation for the culling of 795 adult birds, young poultry and day old chicks, and the destruction of 91 coops and 157 eggs, following the recent outbreak of bird flu in Rinchending, four kilometres from the border town of Phuentsholing.

FDA, FSIS, CDC Collaborate on Methods to Measure Success of Food Safety Programs 3/3/2010 1:35:00 PM The U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) will host a joint public workshop on how best to measure progress in reducing foodborne illnesses on March 30, in Washington, D.C.

FDA Calls on Food Companies to Correct Labeling Violations; FDA Commissioner Issues an Open Letter to the Industry 3/3/2010 12:54:00 PM The U.S. Food and Drug Administration has notified 17 food manufacturers that the labeling for 22 of their food products violates the Federal Food, Drug, and Cosmetic Act.

Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall 3/3/2010 11:55:00 AM Reports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity.

FDA Issues Final Guidance to Boost Development of Cell-based Viral Vaccines 3/3/2010 9:00:00 AM The U.S. Food and Drug Administration today issued final guidance to help manufacturers who are developing safe and effective cell-based viral vaccines to address emerging and pandemic threats.

FDA Survey Finds More Americans Read Information on Food Labels 3/2/2010 5:09:00 PM A majority of consumers read food labels and are increasingly aware of the link between good nutrition and reducing the risk of disease, according to the latest survey of dietary habits released today by the U.S. Food and Drug Administration.

ACIP Provisional Recommendations for the Use of Influenza Vaccines 3/2/2010 4:00:00 PM On February 24, 2010, the ACIP voted on updated recommendations for use of trivalent seasonal influenza vaccine for the 2010-2011 influenza season.

FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland 3/2/2010 3:12:00 PM The U.S. Food and Drug Administration today approved the first generic version of Flomax Capsules 0.4 mg (tamsulosin hydrochloride) to treat benign prostatic hyperplasia (BPH), a condition in which an enlarged prostate gland causes problems with urination.

U.S. Attorney News Release: Boca Raton Man Sentenced for Nutritional Supplement Scam 3/2/2010 11:30:00 AM Jeffrey H. Sloman, United States Attorney for the Southern District of Florida, David W. Bourne, Special Agent in Charge, Food and Drug Administration, Office of Criminal Investigations, Daniel W. Auer, Special Agent in Charge, Internal Revenue Service, Criminal Investigation Division, and Henry Gutierrez, Postal Inspector in Charge, U.S. Postal Inspection Service, announced the February 26, 2010 sentencing of defendant Frank Sarcona, a/k/a Frank Sarcone, a/k/a Dave Johnson, 58, of Boca Raton, FL. U.S. District Court Judge Kenneth A. Marra sentenced Sarcona to a term of 20 years’ imprisonment for conspiracy to commit mail and wire fraud, and criminal contempt of court; conspiracy to commit money laundering; and multiple counts of substantive mail fraud, wire fraud, money laundering, misbranding of a food, and criminal contempt of court.

FDA Announces Meeting Information and Voting Membership of the Tobacco Products Scientific Advisory Committee 3/1/2010 10:37:00 AM The U.S. Food and Drug Administration today announced membership and meeting information for the Tobacco Products Scientific Advisory Committee (TPSAC). The Committee, required through the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), will provide advice, information, and recommendations to FDA on a wide range of tobacco-related issues.

Weekly FluView Map and Surveillance Report for Week Ending Feb 20, 2010 3/1/2010 10:00:00 AM During week 7 (February 14-20, 2010), influenza activity remained at approximately the same levels as last week in the U.S.

International Collaboration: FDA and European Medicines Agency Agree to Accept a Single Orphan Drug Designation Annual Report 2/27/2010 7:23:00 AM In recognition of World Rare Disease Day, the U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions.

FDA Update on the Investigation into the Salmonella Montevideo Outbreak - February 26, 2010 2/27/2010 7:05:00 AM The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, continues to work closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infections associated with certain Italian-style sausage products including salami/salame.

FDA Approves Therapy to Treat Gaucher Disease 2/26/2010 7:26:00 PM The U.S. Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease.

OneTouch SureStep Test Strips (LifeScan): Recall 2/26/2010 5:05:00 PM Test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.

U.S. Attorney News Release: Medical Device Manufacturer Guidant Charged in Failure to Report Defibrillator Safety 2/26/2010 3:03:00 PM U.S. Attorney News release: Medical Device Manufacturer Guidant Charged in Failure to Report Defibrillator Safety Problems to FDA

StatSpin Express 4 Centrifuges Model 510: Recall 2/26/2010 2:05:00 PM Rotor may break and eject pieces of the rotor which may cause serious physical injury to bystanders and expose them to blood-borne infectious micro-organisms.

FDA Update on the Investigation into the Salmonella Montevideo Outbreak - February 25, 2010 2/25/2010 9:08:00 PM The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, continues to work closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infections associated with certain Italian-style sausage products including salami/salame.

Feb 25 - 2009 H1N1 Impact by Race and Ethnicity: Question and Answer 2/25/2010 9:00:00 PM This page provides summary information about the impact of 2009 H1N1 across racial and ethnic groups in the United States.

Feb 24 - CDC Recommends Universal Annual Influenza Vaccination Starting With the 2010-2011 Flu Season 2/25/2010 3:00:00 PM A panel of immunization experts voted today (February 24, 2010) to expand the recommendation for annual influenza vaccination to include all people aged 6 months and older.

U.S. Attorney News Release: Medical Technician Sentenced to 30 Years 2/25/2010 9:07:00 AM Statement by U.S. attorney David Gaouette regarding the sentencing of Kristen Parker

Questions and Answers: Behavioral Risk Factor Surveillance System (BRFSS) 2009 H1N1 Flu Modules for Influenza-like Illness (ILI) and Vaccination 2/25/2010 8:00:00 AM The Behavioral Risk Factor Surveillance System (BRFSS) is a state-based system of health surveys that collects information on health risk behaviors, preventive health practices, and health care access primarily related to chronic disease and injury.

Maryland Veal Calf Dealer Agrees to Close in Response to FDA-Initiated Action 2/24/2010 3:19:00 PM A Maryland veal calf dealer has agreed to shut down as part of a consent decree of permanent injunction, which he entered into after being charged with repeatedly violating federal law and U.S. Food and Drug Administration regulations by selling veal calves with illegal drug residues in their edible tissues.

Study Suggests Potential Reassortment Between Avian and Human Influenza Viruses 2/24/2010 1:46:00 PM
Infection Control Today - A new study published in the Proceedings of the National Academy of Science (PNAS) indicates that a virulent hybrid of the H5N1 avian influenza and human seasonal flu viruses could occur if just one gene is swapped between the two viruses.

FDA Approves Pneumococcal Disease Vaccine with Broader Protection 2/24/2010 12:10:00 PM The U.S. Food and Drug Administration today approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages 6 weeks through 5 years. Prevnar 13 will be the successor to Prevnar, the pneumococcal 7-valent conjugate vaccine licensed by the FDA in 2000 to prevent invasive pneumococcal disease (IPD) and otitis media. The new vaccine extends the protection to six additional types of the disease causing bacteria.

NIH and FDA Announce Collaborative Initiative to Fast-track Innovations to the Public 2/24/2010 10:12:00 AM The U.S. Food and Drug Administration and the National Institutes of Health today unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients.

U.S. Attorney News Release: Woman pleads guilty to poisoning salsa at Lenexa restaurant 2/24/2010 8:08:00 AM Yini De La Torre, has pleaded guilty to putting poison in salsa served to patrons at Mi Ranchito restaurant in Lenexa, Kan. She pleaded guilty to one count of conspiracy to tamper with a consumer product. In her plea, she admitted that while working as a waitress at the Mi Ranchito restaurant in Lenexa she twice added Methomyl-based pesticide to salsa she prepared.

Invirase (saquinavir): Ongoing safety review of clinical trial data 2/23/2010 1:32:00 PM Possible association with abnormal heart rhythms when used in combination with Norvir (ritonavir).

FDA Announces Possible Safety Concern for HIV Drug Combination 2/23/2010 11:36:00 AM The U.S. Food and Drug Administration today announced preliminary data suggesting that Invirase (saquinavir) in combination with Norvir (ritonavir) may have potentially important adverse effects on the heart.

Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety 2/22/2010 3:00:00 PM FDA is reviewing data from a large, long-term clinical study on possible risks for cardiovascular outcomes associated with use of rosiglitazone.

Ear Candles: Risk of Serious Injuries 2/20/2010 4:15:00 PM Consumers warned not to use ear candles because they can cause serious injuries, even when used according to the manufacturer’s directions.

Regulatory Science Update: FDA and International Serious Adverse Events Consortium Complete Third Data Release 2/19/2010 3:33:00 PM The U.S. Food and Drug Administration and the International Serious Adverse Event Consortium (SAEC) today announced the third release of data on the genetic basis of drug-induced liver injury (DILI) and serious skin reactions (SSRs).

WHO Recommends Viruses for Flu Vaccines for the 2010-2011 Northern Hemisphere Flu Season 2/19/2010 2:30:00 PM It is recommended that the following viruses be used for influenza vaccines in the 2010-2011 influenza season (northern hemisphere)

U.S. Attorney New Release: Miami Prescription Drug Diverter Sentenced To 70 Months In Prison 2/19/2010 2:05:00 PM Jeffrey H. Sloman, United States Attorney for the Southern District of Florida, and David W. Bourne, Special Agent in Charge, U.S. Food and Drug Administration (FDA), Office of Criminal Investigations, Miami Field Office, announced that defendant Arnesto Segredo, 43, of Miami, a former prescription drug wholesaler, was sentenced today by U.S. District Court Judge Alan S. Gold to 70 months in prison. Segredo was convicted in August 2009 of one count of conspiring to divert the prescription drugs Serostim and Nutropin AQ, both human growth hormones, and one count of diverting these human growth hormones in interstate commerce.

Weekly FluView Map and Surveillance Report for Week Ending Feb 13, 2010 2/19/2010 10:30:00 AM During week 6 (February 7-13, 2010), influenza activity remained at approximately the same levels as last week in the U.S.

WHO Updates International H1N1 Flu Situation 2/19/2010 10:30:00 AM As of 14 February 2010, worldwide more than 212 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including at least 15921 deaths.

U.S. Attorney New Release: SK Foods former owner charged with RICO violations 2/19/2010 9:10:00 AM United States Attorney Benjamin B. Wagner announced today that a federal grand jury has returned a seven-count indictment charging FREDERICK SCOTT SALYER, 54, of Pebble Beach, with violations of the Racketeer Influenced and Corrupt Organizations Act (RICO), in connection with his direction of various schemes to defraud SK Foods’ corporate customers through bribery and food misbranding and adulteration, and with wire fraud and obstruction of justice.

FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia 2/18/2010 5:06:00 PM The U.S. Food and Drug Administration today approved Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow cancer.

FDA Cancer Drug Approval Rate Highlighted in JNCI 2/18/2010 4:55:00 PM The U.S. Food and Drug Administration’s Office of Oncology Drug Products approved more than 50 new indications for the use of oncology and hematology drugs and biologics between July 2005, when the office began reviewing marketing applications, and the end of 2007, according to a new agency study.

Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements 2/18/2010 3:20:00 PM FDA requires risk management plan and class-labeling changes for all LABAs.

USDA and FDA Coordinating Efforts to Ensure Safety of Produce 2/18/2010 2:27:00 PM The U.S. Department of Agriculture (USDA) and the Food and Drug Administration are working together to achieve the goals of enhancing the safety and quality of fresh produce in ways that take into account the wide diversity of farming operations. We are committed to leveraging the expertise of our partner agencies and working together to ensure that our current produce safety and quality activities are complementary and consistent. While USDA’s Agricultural Marketing Service (AMS) is in the midst of evaluating a proposed marketing agreement for the leafy green industry, the FDA is currently developing a proposed produce safety regulation. It is our expectation that these products will take into account the diverse nature of farming operations and that any marketing agreement would conform to any regulations that may be promulgated by FDA.

FDA Announces New Safety Controls for Long-Acting Beta Agonists, Medications Used to Treat Asthma 2/18/2010 12:00:00 PM The U.S. Food and Drug Administration today announced that drugs in the class of long-acting beta agonists (LABAs) should never be used alone in the treatment of asthma in children or adults. Manufacturers will be required to include this warning in the product labels of these drugs, along with taking other steps to reduce the overall use of these medications.

Exjade (deferasirox): Boxed Warning 2/18/2010 8:55:00 AM Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage.

Maalox Total Relief and Maalox Liquid Products: Medication Use Errors 2/17/2010 7:30:00 PM Consumers who have a history of gastrointestinal ulcers or a bleeding disorder should not use Maalox Total Relief because it contains bismuth subsalicylate, a substance chemically related to aspirin.

FDA Warns about Serious Side Effects from Maalox Product Mix-Ups 2/17/2010 3:41:00 PM The U.S. Food and Drug Administration today warned consumers about the potential for serious side effects from mistakenly using Maalox Total Relief instead of other Maalox products. The two products are intended for the relief of different symptoms and contain different active ingredients.

FDA Update on the Investigation into the Salmonella Montevideo Outbreak 2/17/2010 11:45:00 AM The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, continues to work closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infections associated with certain Italian-style sausage products including salami/salame.

FDA Announces New Safety Plan for Agents Used to Treat Chemotherapy-Related Anemia 2/16/2010 12:21:00 PM The U.S. Food and Drug Administration today approved a risk management program to inform healthcare providers and their patients about the risks of a class of drugs called Erythropoiesis-Stimulating Agents (ESAs). For patients with cancer, the program is also designed to help ensure the appropriate administration of these drugs, which they receive to treat anemia that can occur as a result of chemotherapy.

Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication 2/16/2010 10:55:00 AM FDA requires REMS that ensures that only those hospitals and healthcare professionals who have enrolled and completed training in risk management program will prescribe and dispense ESAs to patients with cancer.

U.S. Attorney News Release: Company pleads guilty to felony misbranding of a drug 2/12/2010 5:44:00 PM Grant C. Jaquith, Temporary Acting United States Attorney for the Northern District of New York, and Mark Dragonetti, Special Agent-in-Charge of the Food and Drug Administration, Office of Criminal Investigations, New York Field Office, announced that THE PLASTIC SURGERY GROUP, LLP (TPSG) of Albany, New York, was sentenced and ordered to pay restitution in the amount of $106,686, and a fine of $200,000, in connection with TPSG’s plea of guilty to one felony count of misbranding drugs, in violation of Title 21, United States Code, Sections 331(k), 352(i)(3), and 333(a)(2). TPSG was sentenced in Federal District Court in Albany, New York by District Judge Thomas J. McAvoy.

U.S. Attorney News Release: Subject sentenced to 51 months for sale of unapproved medical devices 2/12/2010 5:38:00 PM United States Attorney Karen P. Hewitt announced that James Folsom was sentenced today in federal court in San Diego to serve 51 months in custody and a $250,000 fine following his conviction on twenty-six felony counts relating to the sale of unapproved medical devices and the commission of offenses while on pretrial release. The Honorable John A. Houston, United States District Judge, also ordered the destruction of over 450 devices that had been seized by the government during the execution of a search warrant at a selfstorage unit used by the defendant. A federal jury found Folsom guilty of conspiring to ship adulterated and misbranded Rife-type biofrequency devices in interstate commerce, following a two-week trial in 2009.

U.S. Attorney New Release: Business Owner Pleads Guilty to Fraudulently Marketing Dietary Supplements 2/12/2010 3:37:00 PM Beth Phillips, United States Attorney for the Western District of Missouri, announced today that a Springfield, Mo., business owner has pleaded guilty in federal court to her role in a conspiracy to fraudulently market dietary supplements over the Internet with illegal claims that these supplements could prevent, treat or cure a number of diseases. Several Web sites were used to sell nearly $12 million worth of the products in 2005 and 2006.

WHO Updates International H1N1 Flu Situation 2/12/2010 3:30:00 PM As of 7 February 2010, worldwide more than 212 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including at least 15292 deaths.

Weekly FluView Map and Surveillance Report for Week Ending Feb 6, 2010 2/12/2010 12:00:00 PM During week 5 (January 31-February 6, 2010), influenza activity remained at approximately the same levels as last week in the U.S.

CDC 2009 H1N1 and Seasonal Influenza and Hispanic Communities: Questions and Answers 2/11/2010 11:00:00 AM Since April 2009, the 2009 H1N1 influenza virus has been spreading from person-to-person worldwide, affecting all racial and ethnic groups.

Abbreviated Pandemic Influenza Plan Template for Primary Care Provider Offices: Guidance from Stakeholders (PDF) 2/11/2010 10:00:00 AM With the emergence of the 2009 pandemic H1N1 influenza (pH1N1), the importance of the primary care provider's (PCP) role in the community healthcare system has become increasingly evident.

BD Q-Syte Luer Access Devices: Recall 2/9/2010 6:00:00 PM Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.

Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall 2/9/2010 6:00:00 PM Device may not be able to deliver therapy during a cardiac resuscitation attempt.

FDA Approves New Indication for Crestor 2/9/2010 1:45:00 PM On Feb. 8 the U.S. Food and Drug Administration approved the cholesterol-lowering medication Crestor (rosuvastatin) for some patients who are at increased risk of heart disease but have not been diagnosed with it. The new indication is for reducing the likelihood of a heart attack or stroke or the need for a procedure to treat blocked or narrowed arteries in patients who have never been told they have heart disease but are nevertheless at increased risk of a cardiac event.

FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging 2/9/2010 9:54:00 AM The U.S. Food and Drug Administration today announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography.

WHO Updates International H1N1 Flu Situation 2/5/2010 7:20:00 PM As of 31 January 2010, worldwide more than 209 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including at least 15174 deaths.

FDA Issues Guidance to Help Streamline Medical Device Clinical Trials 2/5/2010 11:55:00 AM The U.S. Food and Drug Administration today issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies.

Non-Safety-Related Voluntary Recall Of Sanofi Pasteur 2009 H1N1 Flu Vaccine In Pre-filled Syringes (February 2010) 2/5/2010 11:30:00 AM Why are some of the doses of H1N1 vaccine manufactured in pre-filled syringes being recalled from the market?

Weekly FluView Map and Surveillance Report for Week Ending Jan 30, 2010 2/5/2010 11:30:00 AM During week 4 (January 24-30, 2010), influenza activity remained at approximately the same levels as last week in the U.S.

Tysabri (Natalizumab): Update of Healthcare Professional Information 2/5/2010 11:00:00 AM Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri.

Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical 2/4/2010 2:40:00 PM Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death.

FDA Updates Statement on the Investigation into the Salmonella Montevideo Outbreak 2/4/2010 1:10:00 PM The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, continues to work closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infections associated with certain Italian-style sausage products including salami/salame.

United States Seizes more than 1500 Cases of Food from Wisconsin Distribution Warehouse 2/3/2010 5:21:00 PM At the request of the U.S. Food and Drug Administration, U.S. Marshals on Tuesday seized a wide range of human and animal food products stored under insanitary conditions at Mid-States Closeouts, a distribution warehouse in Ellsworth, Wis. The products were seized under a warrant issued by the U.S. District Court for the Western District of Wisconsin.

FDA Approves Xiaflex for Debilitating Hand Condition 2/3/2010 8:55:00 AM The U.S. Food and Drug Administration today approved Xiaflex (collagenase clostridium histolyticum) as the first drug to treat a progressive hand disease known as Dupuytren's contracture, which can affect a person’s ability to straighten and properly use their fingers.

WHO Updates International H1N1 Flu Situation 2/1/2010 6:30:00 PM 29 January 2010 -- As of 24 January 2010, worldwide more than 209 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including at least 14711 deaths.

FDA Requests $4.03 Billion to Transform Food Safety System, Invest in Medical Product Safety, Regulatory Science 2/1/2010 2:30:00 PM The U.S. Food and Drug Administration is requesting $4.03 billion to promote and protect public health as part of the President’s fiscal year 2011 budget – a 23 percent increase over the agency’s current $3.28 billion budget. The FY 2011 request, which covers the period of Oct.1, 2010, through Sept. 30, 2011, includes increases of $146 million in budget authority and $601 million in industry user fees.

FDA Announces Safety Risk Associated with HIV Drug 2/1/2010 1:28:00 PM The U.S. Food and Drug Administration today announced that non-cirrhotic portal hypertension, a rare, but serious, liver disorder, has been reported in some HIV patients taking Videx/Videx EC (didanosine). Videx is an antiretroviral medicine first approved by the FDA in 1991. Videx EC is a delayed-release version of Videx approved in 2000. Videx/Videx EC is used in combination with other antiretroviral medicines to treat HIV infection in children and adults.

FDA Collaboration Seeks to Speed Development of Pneumococcal Vaccines for Children in Developing Countries 2/1/2010 12:38:00 PM The U.S. Food and Drug Administration (FDA) today announced a collaboration with PATH to advance development of a vaccine to protect children against diseases caused by Streptococcus pneumoniae (pneumococcus), especially pneumonia. Worldwide, the bacterium also causes infections of the brain (meningitis), blood (sepsis), and middle ear (otitis media) and each year kills about 1 million children younger than 5 years of age. The collaboration aims to improve the techniques used to produce effective, safe, and affordable vaccines against pneumococcal disease for children in the developing world. PATH is an international nonprofit organization based in Seattle that creates sustainable, culturally relevant, and affordable solutions to help communities worldwide to break cycles of poor health. The collaborative project, expected to run for two years, is being conducted under the Cooperative Research and Development Agreement (CRADA) program. The program allows federal laboratories and businesses to form partnerships that help expedite research activities.

U.S. gives Zimbabwe health assistance 2/1/2010 9:14:00 AM
Zimbabwe Times - The initiative builds on critical capacities USAID developed to fight H5N1 avian influenza and to support pandemic readiness.

FDA Statement on the Investigation into the Salmonella Montevideo Outbreak 1/29/2010 9:12:00 PM The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture, is working closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infection associated with certain salami products.

FDA Expands Use of Approved Breast Cancer Drug 1/29/2010 6:35:00 PM The U.S. Food and Drug Administration today approved Tykerb (lapatinib) in combination with Femara (letrozole) to treat hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated.

Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension 1/29/2010 3:30:00 PM Risk information added to Warnings/Precautions section and data summary provided