From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 17 Jun 2008 07:21:15 -0500 (CDT)
Subject: FDA News Digest
FDA News Digest
June 17, 2008
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IN THIS WEEK'S ISSUE
» News
-- Administration Proposes More Funding to Improve Food, Medical Product Safety
-- FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs
» Congressional Testimony
» Consumer Health Information Administration Proposes More Funding to Improve Food, Medical Product Safety The administration is amending its budget request for fiscal year 2009 to include an additional $275 million for FDA. The budget amendment proposes increases for core FDA programs in food supply protection; drug, device, and biologics safety; and science and workforce modernizing. http://www.hhs.gov/news/press/2008pres/06/20080609a.html FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs FDA is requiring manufacturers of an older class of drugs known as "conventional" antipsychotics to make changes in labeling to warn that clinical studies indicate that those drugs are associated with an increased risk of death when used in elderly patients treated for dementia.
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.]
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CONGRESSIONAL TESTIMONY
June 12 -- FDA Associate Commissioner for Foods David Acheson, M.D., appeared before the House Subcommittee on Oversight and Investigations.
Subject: ongoing activities to implement the Food Protection Plan
http://www.fda.gov/ola/2008/fpp061208.html
June 10 -- FDA Associate Commissioner for Science Norris Alderson, Ph.D., appeared before the House Subcommittee on Commerce, Trade and Consumer Protection.
Subject: safety of bisphenol A (BPA)
To view an archive of past testimony by FDA officials, go to
http://www.fda.gov/ola/listing.html
Safety Alert: http://www.fda.gov/oc/opacom/hottopics/tomatoes.html 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.
Consumer updates in the spotlight this week are:
http://www.fda.gov/consumer/updates/reporting_guide061008.html
http://www.fda.gov/consumer/updates/reporting061008.html
For the latest in consumer health news from FDA, visit http://www.fda.gov/consumer/default.htm.
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 17 Jun 2008 10:05:46 -0500 (CDT)
Subject: FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'
FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'
Tue, 17 Jun 2008 09:30:00 -0500
Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet.
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 17 Jun 2008 10:36:28 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Guidances Update
You are subscribed to CBER's Guidances for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Guidance for Industry: Indexing Structured Product Labeling (Revision 1) - 6/17/2008
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 17 Jun 2008 11:04:53 -0500 (CDT)
Subject: Beware of Online Cancer Fraud
Beware of Online Cancer Fraud
Tue, 17 Jun 2008 10:38:00 -0500
FDA and the Federal Trade Commission have launched a program targeting online health fraud that takes advantage of people with cancer. Protect yourself with this advice.
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 17 Jun 2008 12:49:20 -0500 (CDT)
Subject: Recent Device Approvals: Biotronik Left Ventricular Pacing Leads
You are subscribed to Recent Device Approvals updates for U.S. Food & Drug Administration (FDA). Information about Biotronik's Stratos LV and Stratos LV T CRT Ps and Corox OTW BP and Corox OTW S BP Left Ventricular Pacing Leads has recently been posted to the FDA website, and is now available.
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 17 Jun 2008 19:03:58 -0500 (CDT)
Subject: Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17)
Tipu's Tiger Chai, Inc Recalls Tipus Tiger Chai Concentrate Because of a Possible Health Risk (June 17)
Tue, 17 Jun 2008 18:48:00 -0500
Tipu's Tiger Chai Inc, of Missoula, Montana is voluntarily recalling its Tipu's Tiger Chai Concentrate because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.
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