September 2009 - FDA News

FDA Opens the Reportable Food Registry Electronic Portal for Industry

FDA Opens the Reportable Food Registry Electronic Portal for Industry
The U.S. Food and Drug Administration has a new way to head off potential cases of foodborne illness the Reportable Food Registry (RFR), where food industry officials must use to alert the FDA quickly, through an electronic portal when they find their products might sicken or kill people or animals. The requirement, a result of legislation, took effect with the launch of the portal.

FDA Approves Vaccines for 2009 H1N1 Influenza Virus The U.S.

FDA Approves Vaccines for 2009 H1N1 Influenza Virus
The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.

FDA Updates "Warning Letters" Web page The U.S. Food and

FDA Updates "Warning Letters" Web page
The U.S. Food and Drug Administration has reorganized and updated the warning letters page in the Inspections, Compliance, Enforcement, and Criminal Investigations section of the FDA Web site.

Cervista? HPV 16/18 These reagents are used with the Invader

Cervista? HPV 16/18
These reagents are used with the Invader Call ReporterTM software to identify DNA from human papillomavirus (HPV) types 16 and 18 in cervical samples. If test results are positive, the patient is likely to be infected with HPV type 16, 18 or both 16... (Approved: 3/12/2009)

Shil La Dang Recalls Gimbob Fish Cake and Modeum, Combination,

Shil La Dang Recalls Gimbob Fish Cake and Modeum, Combination, Sultok and Bean Seolki Rice Cakes Because Of Undeclared Allergens
Shining Marble Corporation dba Shil La Dang, Gardena, CA, is recalling its Gimbob (fish cake sushi), Modeum rice cake, combination rice cake, Sultok rice cake, and Bean Seolki rice cake. The Gimbob Fish Cake does not declare tempura fish, wheat, or soybean as an ingredient. The Modeum, Combination, Sultok, and Bean Seolki rice cakes do not declare chestnuts as an ingredient.

Chulada, Inc. Announces Recall of Saladitos c/ Chile (Salted Plum w/ Chile Powder)
Chulada, Inc. of Burbank, CA is recalling all Chulada Brand Saladitos c/ Chile (Salted Plum w/ Chile Powder) due to elevated levels of lead. Chulada, Inc. learned on 6/10/09 from the California Department of Public Health (CDPH), that Saladitos c/ Chile (Salted Plum w/ Chile Powder) contains high levels of lead that could cause health problems to consumers, particularly infants, small children, and pregnant women.

FDA Study Indicates Most Industry Postmarketing Studies Meet Timelines Makers

FDA Study Indicates Most Industry Postmarketing Studies Meet Timelines
Makers of approved drugs and biologics generally are meeting their regulatory obligations and complete their postmarketing studies in a timely manner, according to a study released today by the U.S. Food and Drug Administration. A review of 1531 open postmarketing studies indicated that over 80 percent are proceeding according to the established timelines, have been submitted for FDA review, or have been determined by the FDA to have met their goals or are no longer needed.

FDA: Institute of Medicine to Study Premarket Clearance Process for

FDA: Institute of Medicine to Study Premarket Clearance Process for Medical Devices
The U.S. Food and Drug Administration today announced that it has commissioned the Institute of Medicine (IOM) to study the premarket notification program used to review and clear certain medical devices marketed in the United States.

FDA Opens the Reportable Food Registry Electronic Portal for Industry

FDA Opens the Reportable Food Registry Electronic Portal for Industry
The U.S. Food and Drug Administration has a new way to head off potential cases of foodborne illness the Reportable Food Registry (RFR), where food industry officials must use to alert the FDA quickly, through an electronic portal when they find their products might sicken or kill people or animals. The requirement, a result of legislation, took effect with the launch of the portal.

BRYAN Cervical Disc The BRYAN Cervical Disc is a titanium

BRYAN Cervical Disc
The BRYAN Cervical Disc is a titanium and polyurethane device that fits between adjacent neck bones (vertebral bodies) to replace a diseased or bulging cervical disc that is causing neck or arm pain. (Approved: 5/12/2009)

FDA Requires Boxed Warning for Promethazine Hydrochloride Injection The U.S.

FDA Requires Boxed Warning for Promethazine Hydrochloride Injection
The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA s authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly. The agency is also alerting health care professionals to the new boxed warning for this product, which is used as a sedative and to treat nausea and vomiting.

Y.S.Trading Corp. Issues Allergy Alert on Undeclared Milk Allergies in "Crown Cookie" (Choco Sanddo)
Y.S.TRADING CORP, of Long Island City NY, is recalling its 161 gram waxed cardboard boxes of "Crown cookie"(Choco Sanddo) because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA Approves Vaccines for 2009 H1N1 Influenza Virus The U.S.

FDA Approves Vaccines for 2009 H1N1 Influenza Virus
The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.

U.S. Attorney News Release: Justice Department Announces Largest Health Care

U.S. Attorney News Release: Justice Department Announces Largest Health Care Fraud Settlement in its History
American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together Pfizer ) have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced today.

FDA Awards Three Grants Designed to Stimulate Development of Pediatric

FDA Awards Three Grants Designed to Stimulate Development of Pediatric Medical Devices
The U.S. Food and Drug Administration today announced the awarding of three grants to stimulate the development and availability of medical devices for children.

FDA: Philips Lifeline Issues Safety Alert for Lifeline Pendant Personal

FDA: Philips Lifeline Issues Safety Alert for Lifeline Pendant Personal Help Buttons
The U.S. Food and Drug Administration today cautioned users of personal emergency response buttons worn around the neck of a potential choking hazard associated with this product.

FDA Opens the Reportable Food Registry Electronic Portal for Industry

FDA Opens the Reportable Food Registry Electronic Portal for Industry
The U.S. Food and Drug Administration has a new way to head off potential cases of foodborne illness the Reportable Food Registry (RFR), where food industry officials must use to alert the FDA quickly, through an electronic portal when they find their products might sicken or kill people or animals. The requirement, a result of legislation, took effect with the launch of the portal.

Sculptra Aesthetic Sculptra Aesthetic is an implant of poly-L-lactic acid

Sculptra Aesthetic
Sculptra Aesthetic is an implant of poly-L-lactic acid (PLLA) microparticles. It is injected into the facial tissue to correct shallow to deep smile lines (nasolabial fold) contour deficiencies and other facial wrinkles. (Approved: 7/28/2009)

Better Buns Inc. Issues Allergy Alert on Undeclared Eggs in

Better Buns Inc. Issues Allergy Alert on Undeclared Eggs in 22oz Europa Baking Company Brand 6 Pack Knot Rolls
Better Buns Inc. is recalling its 22 oz package of Europa Baking Company brand 6 pack Knot Rolls because they may contain undeclared eggs. People who have allergies to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA Requires Boxed Warning for Promethazine Hydrochloride Injection
The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA s authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly. The agency is also alerting health care professionals to the new boxed warning for this product, which is used as a sedative and to treat nausea and vomiting.

Kilwin's Quality Confections, Inc. Conducted Nationwide Recall of Chocolate-Covered Peanuts Because of Possible Health Risk
Kilwin s Quality Confections, Inc. of Petoskey, MI, is recalling all of our 7 ounce packages of chocolate-covered peanuts, and bulk chocolate-covered peanuts, sold in our retail stores, which were sold prior to April 1, 2009, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

FDA Announces Second Annual Science Writers Symposium Science is a

FDA Announces Second Annual Science Writers Symposium
Science is a key foundation for the decisions FDA makes daily on a wide-range of products affecting human and animal health from the most common food ingredients, to complex medical and surgical devices, to lifesaving drugs.

Sabril Approved by FDA to Treat Spasms in Infants and

Sabril Approved by FDA to Treat Spasms in Infants and Epileptic Seizures
Sabril (vigabatrin) Oral Solution has been approved by the U.S. Food and Drug Administration to treat infantile spasms in children ages 1 month to 2 years. Sabril is the first drug in the United States approved to treat the disorder, characterized by a severe type of seizure that usually appears in the first year of life, typically between ages 4 months and 8 months. The disorder can be debilitating because of the frequency of difficult-to-control daily seizures.

HHS and USDA Unveil New Food Safety Consumer Web Site

HHS and USDA Unveil New Food Safety Consumer Web Site at www.foodsafety.gov
Health and Human Services (HHS) Secretary Kathleen Sebelius and Agriculture (USDA) Secretary Tom Vilsack, the co-chairs of the Obama Administration s Food Safety Working Group, unveiled a new consumer Web site today at www.foodsafety.gov. The site is designed to help consumers and families get all the latest information on food safety and food recalls in one convenient place.