Tuesday, July 8, 2008

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update: 1

From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 7 Jul 2008 06:46:27 -0500 (CDT)
Subject: CDRH New Update

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CDRHNEW Logo Date: July 7, 2008

The following new items were added to the CDRH web pages on July 3, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

* Consumer Information on: XIENCE™ V Everolimus Eluting Coronary Stent on the Over-the-Wire (OTW) or Rapid Exchange (RX) Stent Delivery Systems - P070015 Text
* Consumer Information on: Zenith® TX2® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System - P070016 Text

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Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 7 Jul 2008 11:51:23 -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.

Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus From Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Cells, Tissues, and Cellular and Tissue-Based Products; Request for Data (Federal Register)
Posted: 7/7/2008


Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 7 Jul 2008 15:55:28 -0500 (CDT)
Subject: FDA News Digest for July 7, 2008

FDA News Digest

July 7, 2008

_____________________________________

IN THIS WEEK'S ISSUE

» News

-- FDA Food Protection Plan Shows Significant Progress

» Safety Alerts/Recalls

» Upcoming Public Meetings

» Consumer Health Information

__________________________________________

NEWS

FDA Food Protection Plan Shows Significant Progress

FDA has released the Food Protection Plan Progress Report, which shows significant areas of activity to further improve the safety of the country’s food supply since the agency unveiled its Food Protection Plan in November 2007. The improvements highlight the agency’s efforts to address domestic and global changes in our food supply. The Food Protection Plan focuses on prevention (building safety in from the start), intervention (using targeted risk-based inspections and testing), and response (responding rapidly when problems are identified).

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01856.html

-- Progress report: http://www.fda.gov/oc/initiatives/advance/food/progressreport.html

-- Food Protection Plan: http://www.fda.gov/oc/initiatives/advance/food/plan.html

To view an archive of recent FDA news releases, go to

http://www.fda.gov/opacom/hpnews.html.

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.

CONSUMER HEALTH INFORMATION

Consumer updates in the spotlight this week are:

Heartworm Prevention in Your Pet

http://www.fda.gov/consumer/updates/heartworm061908.html

How to Dispose of Unused Medicines

http://www.fda.gov/consumer/updates/drug_disposal062308.html

To receive all consumer updates by e-mail, go to http://www.fda.gov/consumer/consumerenews.html.

For the latest in consumer health news from FDA, visit http://www.fda.gov/consumer/default.htm.

Thanks for subscribing to FDA News Digest.

Our next issue will be sent July 14.


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