Update: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 5 May 2008 07:16:35 -0500 (CDT)
Subject: FDA Data Standards Update - Stability Data Standard Update
Greetings,
The FDA Data Standards Council's Stability Data's web page http://www.fda.gov/oc/datacouncil/stability.html was updated Monday, May 5, 2008, to include a link to the following:
1. Product Stability Data Pilot Project Completion Announcement
2. eStability web site
Lonnie Smith
Project Manager
Food and Drug Administration
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 5 May 2008 08:05:59 -0500 (CDT)
Subject: The May 2008 FDA Patient Safety News is now available...
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You can find more information about
FDA Licenses New Hemophilia Treatment
Xyntha is produced without additives from human or animal material, which can further minimize the risk of infection...
Unsafe Use of Extended-Release Tussionex Suspension
Overdose of long-acting hydrocodone cough suppressant can result in respiratory depression and death...
Liver Injury with Tysabri (natalizumab)
Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury...
Updated Labeling Changes for Tamiflu (oseltamivir phosphate) and Relenza (zanamivir)
Patients with influenza should be closely monitored for signs of abnormal behavior...
New Instructions for Using Talecris IG Syringes
How to use HyperRAB S/D and GamaSTAN S/D 2 mL syringes properly in certain circumstances...
Hepatotoxicity with Prezista (darunavir)
Appropriate laboratory testing should be conducted before starting treatment and patients should also be monitored during treatment...
Information on Mortality Rates with the AneuRx Stent Graft System
Patients should meet the appropriate risk-benefit profile...
Mistakenly Swallowing Inhaler Capsules
Respiratory problems will not be treated if patients mistakenly take the capsules orally rather than with an inhaler...
Choosing the Correct Test Strip for a Blood Glucose Meter
Using the wrong strip in any brand of blood glucose meter could result in erroneous readings or no readings at all...
For more
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Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 5 May 2008 10:07:16 -0500 (CDT)
Subject: FDA News Digest for May 5, 2008
FDA News Digest
May 5, 2008
_____________________________________
IN THIS WEEK'S ISSUE
» News
-- FDA Clears Coronary Artery Plaque Imaging Device
-- Amitiza Approved for Irritable Bowel Syndrome with Constipation
-- Agency Plans to Fill More Than 1,300 Jobs in Major Hiring Initiative
-- 'FDA Patient Safety News' Video, Podcast Available
» Consumer Health Information FDA Clears Coronary Artery Plaque Imaging Device FDA has cleared for marketing the InfraReDx LipiScan NIR Catheter Imaging System, a device doctors can use to see inside blood vessels to assess the fat content of plaque that builds up on coronary artery walls. Plaque is made up of cholesterol-rich fat, calcium, and other substances found in blood. As plaque accumulates on the artery wall, it reduces blood flow to the heart muscle and increases the risk of blood clots, which can lead to a heart attack. The new device can help doctors identify plaques that may be of particular concern. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01827.html Amitiza Approved for Irritable Bowel Syndrome with Constipation FDA has approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in women aged 18 and older. There is currently no prescription drug therapy for IBS-C. With this approval, Amitiza becomes the only FDA-approved medical treatment for IBS-C available in the Agency Plans to Fill More Than 1,300 Jobs in Major Hiring Initiative Biologists, chemists, medical officers, mathematical statisticians and investigators are among the experts in demand as FDA begins a multi-year hiring initiative. The agency is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and effectiveness of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation. In fiscal year 2008 alone, the agency is looking to fill more than 600 new positions and to backfill over 700 others to implement the FDA Amendments Act of 2007, the Food Protection Plan, and the Import Safety Action Plan. That's nearly triple the number of people hired between 2005 and 2007. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01829.html
FDA has posted the latest edition of "FDA Patient Safety News," a free Web-based video news program. Aimed primarily at health professionals, the program features information on new drugs, biologics, and medical devices, as well as FDA safety notifications and product recalls.
-- To view video or text version: http://www.fda.gov/psn
-- To access Podcast: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/podcast.cfm
To access the RSS feed of FDA news releases, go to
http://www.fda.gov/bbs/topics/news/rssPress.xml.
[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
_____________________________________________
SAFETY ALERTS/RECALLS
For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated
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.]
____________________________________________________________________
UPCOMING PUBLIC MEETINGS
For a complete list of upcoming meetings, seminars, and other public events sponsored
or co-sponsored by FDA, go to http://www.fda.gov/opacom/hpmeetings.html.
This week's spotlight consumer updates are:
http://www.fda.gov/consumer/updates/antibiotics050108.html
http://www.fda.gov/consumer/updates/beefsafety042508.html
For the latest in consumer health news from FDA, visit http://www.fda.gov/consumer/default.htm.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 5 May 2008 11:04:28 -0500 (CDT)
Subject: Lezza Blue Raspberry Water Ice Recalled from Three Midwestern States (May 2)
Lezza Blue Raspberry Water Ice Recalled from Three Midwestern States (May 2)
Mon, 5 May 2008 10:15:00 -0500
Cedar Crest Specialties, Inc. announced a recall on one lot code of Lezza Blue Raspberry Water Ice in round plastic pint containers with a lot code of 2116 because it may contain undeclared milk protein. The product was distributed to retail outlets in Illinois, Wisconsin, and Minnesota during 2006 and 2007.
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