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Update : 1
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: March 31, 2008 |
The following new items were added to the CDRH web pages on March 28, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Consumer Information on: Dako TOP2A FISH pharmDx™ Kit - P050045 |  |
| Consumer Information on: FreeStyle Navigator® Continuous Glucose Monitoring System - P050020 | |
Update : 2
Subject: FDA Data Standards Update - UNII Update
The FDA Data Standards Council's website was updated Monday, March 31, 2008, to include an update to the list of Unique Ingredient Identifiers (UNIIs).
Hyperlinks to the updated list of UNIIs can be found on either of these web pages:
Substance Registration System - Unique Ingredient Identifier: http://www.fda.gov/oc/datacouncil/SRS.htm
Structured Product Labeling Resources: http://www.fda.gov/oc/datacouncil/spl.html
Lonnie Smith
Project Manager
Food and Drug Administration
Update : 3
Subject: Stonyfield Farm Announces Nationwide Voluntary Recall of 6-Ounce Fat Free Blueberry Yogurts (March 28)
Stonyfield Farm Announces Nationwide Voluntary Recall of 6-Ounce Fat Free Blueberry Yogurts (March 28)
Mon, 31 Mar 2008 10:23:00 -0500
Organic yogurt maker Stonyfield Farm has announced a voluntary product recall of its non-fat blueberry yogurt products. The recall comes in response to the possibility of glass fragments in the product.
Update : 4
Subject: JARD Marketing Corp. Announces Recall of Some Fresh Cut and Foodservice Fruit Products Containing Cantaloupe Due To Possible Salmonella Contamination (March 28)
JARD Marketing Corp. Announces Recall of Some Fresh Cut and Foodservice Fruit Products Containing Cantaloupe Due To Possible Salmonella Contamination (March 28)
Mon, 31 Mar 2008 11:52:00 -0500
JARD Marketing, Lawrence, Massachusetts is recalling selected fresh cut fruit products which contain cantaloupe which has the potential to be contaminated with Salmonella. On March 26, 2008, JARD marketing was requested by its supplier T. M. Kovacevich International Inc, to recall products produced with cantaloupe from Agropecuaria Montelibano.
Update : 5
Subject: Bay Valley Foods Issues Allergy Alert on Undeclared Fish, Soy and Wheat in America's Choice Classic Caesar Dressing (March 31)
Bay Valley Foods Issues Allergy Alert on Undeclared Fish, Soy and Wheat in America's Choice Classic Caesar Dressing (March 31)
Mon, 31 Mar 2008 14:39:00 -0500
Bay Valley Foods is recalling 535 cases of America’s Choice Classic Caesar Dressing because some of the bottles produced in February 2008 have an incorrect ingredient label on the back of the bottle. The incorrect label on the back includes ingredient and nutrition information for Chunky Blue Cheese Dressing and does not declare the presence of fish, soy and wheat. Consumers who have allergies to fish, soy and wheat run the risk of a serious or life threating allergic reaction if they consume the mislabeled product.
Update : 6
Subject: FDA News Digest for March 31, 2008
FDA News Digest
March 31, 2008
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IN THIS WEEK'S ISSUE
» News
-- Recommendations Made on Devices That Treat Blocked Heart Arteries
» Consumer Health Information Recommendations Made on Devices That Treat Blocked Heart Arteries FDA has issued draft guidelines to aid the development, testing and manufacture of coronary drug-eluting stents, which are devices used to treat blocked heart arteries. FDA and the clinical community have been closely monitoring these devices, including concerns over clot formation in some patients several years after implantation. The draft guidelines outline the agency's recommendations for providing data to better address the clot issue and other potential safety concerns. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01810.html 25 Drugs, Biologics Identified for Safety Plan Requirements FDA has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy (REMS). FDA can require manufacturers to submit a REMS when a drug first comes on the market or later if FDA becomes aware of new safety data about the drug. Manufacturers of the 25 drugs and biologic products identified in today's notice must submit to the agency a proposed REMS by Sept. 21, 2008. FDA Seeks Civil Penalties from FDA is seeking a $2.2 million penalty against
SAFETY ALERTS/RECALLS
Safety Alerts:
› FDA is advising consumers not to buy or use "Blue Steel" or "Hero" products, marketed as dietary supplements throughout the United States, because they are considered unapproved drugs and have not been proven to be safe or effective. These products contain undeclared ingredients, which may dangerously affect blood pressure level. They are promoted and sold over the Internet for the treatment of erectile dysfunction (ED) and for sexual enhancement. They are labeled as dietary supplements but do not qualify as such because they contain undeclared and unapproved substances similar in chemical structure to sildenafil, the active ingredient in the ED drug Viagra.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01809.html
› FDA also is advising consumers not to buy or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.
Food Recalls:
› Honduran Cantaloupes grown by Agropecuaria Montelibano
Reason for recall: Salmonella contamination
› Certain batches of Stonyfield Organic Fat Free Blueberry Yogurt, 6-oz. cups
Reason for recall: reported plastic or glass fragments in product
http://www.fda.gov/oc/po/firmrecalls/stonyfield03_08.html
products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.
To access the RSS feed of FDA recalls information, go to
http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml
[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
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UPCOMING PUBLIC MEETINGS
April 1-2 -- Anti-Infective Drugs Advisory Committee
Under discussion: product development and clinical trial design for community-acquired pneumonia
Location:
http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-814.htm
April 4 -- Quality System Regulation Educational Forum on Design Controls, a public workshop for regulated industry, especially small businesses
Location: Dallas, Texas
http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-20077.htm
April 7-8 -- QT and Arrhythmia Issues in Drug Development
Under discussion: development of pharmaceutical agents, as well as challenges and solutions
Location: Bethesda, Md.
April 10-11 -- Cellular, Tissue and Gene Therapies Advisory Committee
Under discussion: safety testing for cellular therapy products derived from human embryonic stem cells
Location: Gaithersburg, Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-24629.htm
For a complete list of meetings, seminars, and other public events sponsored
or co-sponsored by FDA, go to http://www.fda.gov/opacom/hpmeetings.html.
http://www.fda.gov/consumer/updates/ultrasound032408.html
› Avoid Fetal “Keepsake” Images, Heartbeat Monitors
http://www.fda.gov/consumer/updates/keepsakevideo032408.html
Update : 7
Subject: The April 2008 MedSun Newsletter is now available...
Medical Product Safety Network
Highlighted articles include:
Epidural Conduction Device Fractures and Complications of Retained Fragments
The article gives tips to nurse anesthetists on how to prevent potential problems through good practices and encourages the practice of recording catheter retention in medical records and informing patients of retained devices...
FDA Requests Comments on Dissemination of Information on Unapproved Uses of Medical Products
The U.S. Food and Drug Administration (FDA) issued draft guidance on "Good Reprint Practices" for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices...
FDA Approves Drug-Eluting Stent for Clogged Heart Arteries
Managing Medical Device Recalls
Provides tips to healthcare facilities on what to do when a medical device recall has been initiated...
Surveyed hospitals: Only 10-30 Percent Use Successful CA-UTI Prevention Practices
A recent national survey of urinary tract prevention infection practices revealed that more than 50 percent of hospitals did not have a monitoring system for patients with indwelling catheters and greater than 70 percent did not monitor the duration the catheter was in place...
The results indicated that perceived usefulness, perceived ease of use, subjective norm, and trust had a significant effect on a professional's intention to use an adverse event reporting system...
Prevent Life-Threatening Communication Breakdowns
A patient died after uneventful elective surgery because his implantable cardioverter defibrillator (ICD) was not turned back on after the procedure...
FDA Reminds Healthcare Professionals About Falsely Elevated Glucose Levels
FDA is reminding healthcare professionals of the potential for life-threatening falsely elevated glucose readings in patients who have received parenteral products containing maltose or galactose, or oral xylose and are subsequently tested using glucose dehydrogenase pyrroloquinolinequinone based glucose monitoring systems...
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