From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 5 Aug 2008 07:16:36 -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.
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 5 Aug 2008 07:44:01 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: August 5, 2008 |
The following new items were added to the CDRH web pages on August 4, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers |  |  |
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 5 Aug 2008 12:07:04 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Recalls, Withdrawals, Field Corrections & Notifications Update
You are subscribed to CBER's Recalls, Withdrawals, Field Corrections & Notifications for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Recall of m2000sp Instrument - Abbott Molecular - 6/30/2008
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 5 Aug 2008 14:05:02 -0500 (CDT)
Subject: FDA Approves 2008-2009 Flu Vaccines
FDA Approves 2008-2009 Flu Vaccines
Tue, 05 Aug 2008 13:39:00 -0500
The U.S. Food and Drug Administration (FDA) today announced that it has approved this year's seasonal influenza vaccines that include new strains of the virus likely to cause flu in the United States during the 2008-2009 season. The six vaccines and their manufacturers are: CSL Limited, Afluria; GlaxoSmithKline Biologicals, Fluarix; ID Biomedical Corporation of Quebec, FluLaval; MedImmune Vaccines Inc., FluMist; Novartis Vaccines and Diagnostics Limited, Fluvirin; and Sanofi Pasteur Inc., Fluzone.
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 5 Aug 2008 14:56:45 -0500 (CDT)
Subject: FDA Data Standards Update - Terminology Update
Greetings,
The FDA Data Standards Council's website was updated Tuesday, August 5, 2008, to include the following updated information:
SPL web page: (added link to additional validation files) http://www.fda.gov/oc/datacouncil/spl.html
Terminology lists: (added XML files for package types and UNIIs) http://www.fda.gov/oc/datacouncil/terminology_lists.zip
Additional Validation Files: (added XML files for validation lists such as solid, oral dosage form and counter-ion) http://www.fda.gov/oc/datacouncil/additional_validation_only_lists.zip
UNII zip file: (added new UNIIs) http://www.fda.gov/oc/datacouncil/UNIIs.zip
CodeSystem OID: (added new OID for FDA Regulatory Compliance Service) http://www.fda.gov/oc/datacouncil/cdsys.html
Units of Measure: (added new units of measure - see list below) http://www.fda.gov/oc/datacouncil/splncicodes.html#potency
CELL CULTURE INFECTIOUS DOSE 50%
COLONY FORMING UNITS
FOCUS-FORMING UNITS
PLAQUE-FORMING UNITS
TISSUE CULTURE INFECTIOUS DOSE 50%
Lonnie Smith
Project Manager
FDA Data Standards Council
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 5 Aug 2008 15:05:07 -0500 (CDT)
Subject: Drug Shortages: Drugs to be Discontinued; Geref Diagnostic
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Drug Shortages: Drugs to be Discontinued; Geref Diagnostic
Tue, 05 Aug 2008 12:56:00 -0500
EMD Serono has made a business decision to discontinue this product.
Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 5 Aug 2008 15:43:33 -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.
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