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Last Updated: May 20, 2008 - 6:56:09 AM |
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General Health
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Drug News
Medical Devices; Immunology and Microbiology Devices;
The Food and Drug Administration (FDA) is classifying Plasmodium species antigen detection assays into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
May 20, 2008 - 6:37:19 AM
General Health
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Other News
Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc)
This draft guidance, when finalized, will represent the Food and
Drug Administration’s (FDA’s) current thinking on this topic. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. You can use an alternate approach if
the approach satisfies the requirements of the applicable statutes or
regulations. If you want to discuss an alternate approach, contact the
appropriate FDA staff. If you cannot identify the appropriate FDA
staff, call the appropriate number listed on the title page of this
guidance.
May 20, 2008 - 6:32:30 AM
General Health
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Drug News
Solodyn (minocycline HCL) Extended Release Tablets 90 mg
Medicis and FDA notified healthcare professionals of the
recall of lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of
Solodyn Extended Release Tablets.
May 19, 2008 - 10:18:08 PM
General Health
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Drug News
Cardinal Alcohol-Free Mouthwash
Hydrox Labs issued a voluntary recall of another lot of
Alcohol-Free Mouthwash because samples of the product tested were
positive for
Burkholderia cepacia (B. cepacia). The affected product lot number is 26230.
May 19, 2008 - 10:15:45 PM
Misc. News
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Consumer Affair
Strengthening Beef Safety
The
Food and Drug Administration (FDA) has issued a final regulation
barring certain cattle materials from all animal feed, including pet
food.
FDA regulates animal feed and drugs. The U.S.
Department of Agriculture (USDA) regulates meat. Together the agencies
enforce regulations that ensure that specific risk materials are kept
out of the human food supply.
May 19, 2008 - 10:10:48 PM
Misc. News
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Consumer Affair
Start at the Store: 7 Ways to Prevent Foodborne Illness
Safeguarding your home against foodborne illnesses begins not at
home, but at the supermarket, grocery store, or any other place where
you buy food that you plan to store and serve.
May 19, 2008 - 10:09:10 PM
Misc. News
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Recalls & Alerts
FSIS: Pork crackling products may be tainted with Salmonella
The U.S. Department of Agriculture's Food Safety and Inspection Service
(FSIS) issued a public health alert today saying 1,100 pounds of fully
cooked pork crackling products produced at Sofia Chicharones, Inc., a
Miami, Fla., establishment may be contaminated with Salmonella.
May 19, 2008 - 6:02:49 PM
Diet & Health
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Cancer
Green tea, Lingzhi mushroom extract combo slows sarcomas
A combination of the active ingredients from reishi or Lingzhi
mushrooms and green tea may be used to treat sarcoma, according to two
Chinese studies by researchers at the Pharmanex BJ Clinical
Pharmacology Center in Beijing.
May 19, 2008 - 5:35:09 PM
General Health
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Other News
Google Health: What you need to know
Google Health is a Google online service available at
www.google.com/health. With this service, you can keep his doctors
up-to-date on your medical records, let doctors share lab test results
and keep the medical records in a place without risking of losing them
because of a move, change in jobs or health insurance.
May 19, 2008 - 4:40:34 PM
General Health
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Government
FDA Takes Action against Cream Cheese Companies, Executives
The U.S. Food and Drug Administration today announced the shut down
of cream cheese and seafood operations at Lifeway Foods, Inc. and its
subsidiary, LFI Enterprises, Inc., both Illinois companies, until they
are found compliant with food-safety laws. A consent decree of
permanent injunction, signed by both corporations and two of their top
executives, Julie and Edward Smolyansky (the defendants), halts cream
cheese and seafood processing in facilities in Skokie, Ill., and
Philadelphia, Pa.
May 19, 2008 - 3:01:14 PM
General Health
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Government
FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc.
The U.S. Food and Drug Administration (FDA) today announced that Scientific
Laboratories Inc., and its president, Rajeshwari Patel, and chief executive
officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and
are barred from manufacturing and distributing drug products until they bring
their manufacturing operations into compliance with law and obtain approval
for their products.
May 19, 2008 - 2:59:40 PM
General Health
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Mental Health
Mom's prenatal stress raises risk of asthma, allergy in babies
A new study has found more of allergy antibodies in babies whose moms
experienced stress during pregnancy, suggesting that women's prenatal
stress may predispose their children to asthma and allergy later in
their life.
May 19, 2008 - 1:24:01 PM
Misc. News
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Consumer Affair
USDA Offers Food Safety Tips for a Successful Summer Grilling Season
The days are getting longer, the weather is getting warmer and Memorial
Day is fast approaching - all signs that the summer grilling season is
nearly upon us. As you make plans to kick off the summer grilling
season at your Memorial Day barbecue this year, USDA reminds you that
safe food handling skills are the key to making your cookout a big hit
with your guests.
May 19, 2008 - 10:04:40 AM
General Health
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Diseases
Cases Of Recreational Water Illnesses On The Rise
Cryptosporidiosis or Crypto, a chlorine-resistant parasite, is likely to pose an even bigger challenge in the future
May 19, 2008 - 9:53:50 AM
Food & Health
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Laws & Politics
FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled
The
U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena,
Texas, food processing company, to shut down and immediately recall all products
manufactured from its Texas facility since 2007.
May 19, 2008 - 8:47:26 AM
General Health
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Drug News
Questions and Answers on FluMist
FluMist is a live attenuated influenza virus vaccine (LAIV) approved
to prevent illness caused by influenza A and B viruses in individuals
2-49 years of age.
May 19, 2008 - 7:19:57 AM
General Health
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Drug News
Medicis Announces Voluntary Recall of Solodyn® (minocycline HCL, USP) 90 Mg Tablets
Medicis today announced that the Company is voluntarily
recalling lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of
the antibiotic SOLODYN® (minocycline HCl, USP) Extended Release
Tablets, 90 mg, 30-count bottles (NDC 99207-461-30). Medicis has
received a report that one bottle in lot number B080037 contains
AZASAN® (azathioprine tablets) 75 mg (NDC 65649-231-51) instead of
SOLODYN® (minocycline HCl, USP) Extended Release Tablets, 90 mg.
AZASAN® is an immuno-suppressive agent used in transplant patients to
prevent kidney rejection and for the treatment of rheumatoid arthritis.
May 19, 2008 - 7:11:08 AM
Diet & Health
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Cancer
Vitamin D may cut breast cancer risk
Breast cancer patients with higher levels of vitamin D were far more
unlikely to die from the disease and far more unlikely to have
recurrence of it than those with lower levels of the vitamin, according
to a Canadian study.
May 18, 2008 - 5:26:59 PM
Misc. News
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Recalls & Alerts
Chicago firm recalls beef possibly tainted with E. coli
The U.S. Food Safety and Inspection Service announced on May 16 that
JSM Meat Holdings Company, Inc., based out of Chicago, Illinois, is
voluntarily recalling beef products intended for use in ground products
due to possible contamination with E. coli O157:H7.
May 18, 2008 - 4:35:34 PM
Food & Health
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Cooking & Packing
Cancer Experts Issue Seasonal Warning on Grilling
Smart Precautions Can Reduce Grilling Risks, But
What You Grill Should be Central Concern
May 18, 2008 - 12:10:14 PM
General Health
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Other News
GKS petition threatens weight loss supplements
Many may not have known this: GlaxoSimthKline (GSK) on April
17, 2008 submitted its 33-page petition to the FDA asking the agency to
consider weight loss claims for dietary supplements as disease claims.
May 18, 2008 - 10:25:56 AM
Diet & Health
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Body Weight
Dairy products do not help people lose weight
A review published in the May 2008 issue of Nutrition Reviews suggests
that recent claims that low-fat diary products or calcium can help
people lose weight are more of hype than science.
May 18, 2008 - 10:00:26 AM
Diet & Health
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Cancer
Study explains why vitamin D prevents prostate cancer
A study by researchers at the University of Rochester Medical Center
provides an explanation why vitamin D may prevent prostate cancer and
maybe other types of cancer.
May 18, 2008 - 9:20:41 AM
Diet & Health
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General Health
Vitamin D may cut risk of death from chronic kidney disease
Taking active vitamin
D supplements may help cut risk of death for people with moderate to severe
chronic kidney disease, according to a study published in the August issue of
the Journal of the American Society of Nephrology.
May 18, 2008 - 8:40:03 AM
Misc. News
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Recalls & Alerts
Illinois Firm Recalls Beef Products Due To Possible E. coli O157:H7 Contamination
JSM Meat Holdings Company, Inc., a Chicago, Ill., firm, is voluntarily
recalling an undetermined amount of beef products intended for use in
ground products because they may be contaminated with E. coli O157:H7,
the U.S. Department of Agriculture's Food Safety and Inspection Service
announced today.
May 18, 2008 - 8:09:59 AM
Misc. News
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Recalls & Alerts
New York Firm Recalls Ground Beef Products That May Contain Pieces of Plastic
Fairbank Reconstruction Corp., an Ashville, NY, establishment, is
voluntarily recalling approximately 22,481 pounds of ground beef
products that may contain pieces of plastic, the U.S. Department of
Agriculture's Food Safety and Inspection Service announced today.
May 18, 2008 - 8:08:34 AM
General Health
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Other News
Use of Enhanced Surveillance for Hepatitis C Virus Infection to Detect a Cluster Among Young Injection-Drug Users
Infection with hepatitis C virus (HCV) is a leading cause of chronic liver disease in the United States
(
1). Chronic hepatitis B and C virus infections were added to the
nationally notifiable diseases list in 2003
(
2). Approximately 3.2 million persons in the United States have chronic HCV infection
(
3). The most common risk factor for HCV infection
is illicit drug use (specifically injection-drug use [IDU])
(
3,4), although approximately one third to one half of cases
have no identified risk factor (
4; New York State Department of Health [NYSDOH], unpublished data, 2008).
May 18, 2008 - 7:42:29 AM
General Health
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Other News
Acute Hepatitis C Virus Infections Attributed to Unsafe Injection Practices
On January 2, 2008, the Nevada State Health Division (NSHD)
contacted CDC concerning surveillance reports received by the Southern
Nevada Health District (SNHD) regarding two persons recently diagnosed
with acute hepatitis C.
May 18, 2008 - 6:54:35 AM
Diet & Health
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Cancer
Vitamin D and Breast Cancer - Part one
Vitamin D plays an incredibly important role in cancer prevention,
survival and treatment. We summarized several reports on vitamin D and
breast cancer to give readers some ideas about the importance of this
vitamin. We will continue publishing more articles on this issue.
May 17, 2008 - 1:27:40 PM
General Health
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Drug News
Varenicline (marketed as Chantix) Information
FDA is issuing this Alert to highlight important revisions to the
WARNINGS and PRECAUTIONS sections of the full prescribing information
for Chantix regarding serious neuropsychiatric symptoms.
May 16, 2008 - 5:12:02 PM
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