Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 10 Sep 2008 08:03:59 -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: September 10, 2008 |
The following new items were added to the CDRH web pages on September 9, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 020 |  |  |
Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 10 Sep 2008 09:57:51 -0500 (CDT)
Subject: FDA Data Standards Update - Drug Stability Reporting (eStability) Working Group Vendor Meeting - October 7, 2008
Greetings,
The FDA Data Standards Council's website was updated on Tuesday, September 9, 2008, to include the following announcement:
Drug Stability Reporting (eStability) Working Group Vendor Meeting - October 7, 2008
Please see this web page for more information: http://www.fda.gov/oc/datacouncil/drug_stability_reporting_vendor_meeting_10_07_08.html
Lonnie Smith
Project Manager
FDA Data Standards Council
Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 10 Sep 2008 10:01:26 -0500 (CDT)
Subject: FDA Data Standards Update - SPL Vendor Training - Follow-up Session - October 8, 2008
Greetings,
The FDA Data Standards Council's website was updated on Tuesday, September 9, 2008, to include the following announcement:
SPL Vendor Training - Follow-up Session - October 8, 2008.
Please see this web page for more information: http://www.fda.gov/oc/datacouncil/spl_training_10_08_2008.html.
Lonnie Smith
Project Manager
FDA Data Standards Council
Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 10 Sep 2008 10:44:46 -0500 (CDT)
Subject: CDER New September 9
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September 9, 2008
- Cyber Letters for Years: 2005, 2006, 2007 (updated)
- Guidance for Industry: Concept Papers
- New and Generic Drug Approvals
- Monistat 3 (miconazole nitrate) Vaginal Cream, Johnson and Johnson Healthcare Products, Manufacturing Change or Addition
- Photofrin (porfimer sodium) Injection, Axcan Pharma US, Inc., Efficacy Supplement with Clinical Data to Support
Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 10 Sep 2008 11:46:22 -0500 (CDT)
Subject: FDA Warning Letters Update
You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 10 Sep 2008 12:34:13 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 9/10/2008
Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 10 Sep 2008 08:02:27 -0500 (CDT)
Subject: Lucky Country Inc. Recalls All Natural Black Licorice Products (September 5)
Lucky Country Inc. Recalls All Natural Black Licorice Products (September 5)
Wed, 10 Sep 2008 07:24:00 -0500
Lucky Country Inc. of Lincolnton, NC is recalling all of its natural black licorice products from California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Massachusetts, Minnesota, New Hampshire, Pennsylvania, Utah, Virginia, and Washington State due to elevated levels of lead.
Message: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 10 Sep 2008 13:03:35 -0500 (CDT)
Subject: Voluntary Recall: Wegmans In-Store Made Bagels (September 10)
Voluntary Recall: Wegmans In-Store Made Bagels (September 10)
Wed, 10 Sep 2008 12:41:00 -0500
Wegmans Food Markets, Inc. is voluntarily recalling all varieties of its in-store made bagels and bialys (flattened bagels with various toppings, i.e. pizza) sold in the bakery and purchased between August 24 and September 9, 2008. This recall is being initiated because the bagels may contain pieces of a metal spring from a mixer that entered the dough, which is produced at Wegmans' Central Bakeshop in Rochester, posing a possible choking hazard.
Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 10 Sep 2008 16:03:16 -0500 (CDT)
Subject: Enforcement Report for September 10, 2008
Enforcement Report for September 10, 2008
Wed, 10 Sep 2008 13:16:00 -0500
Weekly report by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
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