Saturday, September 20, 2008

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

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 19 Sep 2008 06:51:25 -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.

Supplement Approval: Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant (Gardasil) - Statistical
Review and Evaluation
Posted: 9/18/2008

Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 19 Sep 2008 07:57:12 -0500 (CDT)
Subject: CDER New 9/18/2008

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Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

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September 18, 2008

Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 19 Sep 2008 08:07:42 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Proposed and Final Rules Update

You are subscribed to CBER's Proposed and Final Rules for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

FEDERAL REGISTER: FDA Regulations; Technical Amendment; Final Rule; Correction - 9/19/2008

Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 19 Sep 2008 08:20:49 -0500 (CDT)
Subject: CDRH New Update

Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule
CDRHNEW Logo Date: September 19, 2008

The following new items were added to the CDRH web pages on September 18, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

* Draft Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence Text PDF
* Maturity Health Matters: FDA Health News for Older Adults and Their Caregivers (Fall 2008 Issue) Text

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Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 19 Sep 2008 10:05:13 -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.

FEDERAL REGISTER: FDA Regulations; Technical Amendment; Final Rule; Correction - 9/19/2008

Public Workshop: Structured Product Labeling Content of Labeling and Electronic Drug Establishment Registration and Drug Listing for the Biologics Industry
Posted: 9/19/2008

Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 19 Sep 2008 11:06:51 -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.

Vacancy Announcement - Biologist/Lead/Supv Biologist
Posted: 9/19/2008

Vacancy Announcement - Microbiologist /Lead /Supv Microbiologist
Posted: 9/19/2008

Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 19 Sep 2008 14:23:45 -0500 (CDT)
Subject: CDER New 7/19/2008

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Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

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September 19, 2008

Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 19 Sep 2008 19:43:46 -0500 (CDT)
Subject: The FDA this Week: Andy's Take -- FDA: Listening and Leading: How We Promote and Protect Your Health

The FDA this Week: Andy's Take -- FDA: Listening and Leading: How We Promote and Protect Your Health
Fri, 19 Sep 2008 20:52:00 -0500

Welcome to Andy's Take. I'm Susan Winckler, FDA's Chief of Staff, and I am pleased to bring you this week's edition. In a typical week, you may hear many news reports that mention the FDA. Those reports provide a brief snapshot of FDA work on your behalf.

My Take is that depending on your interest, you may only have seen one of those many snapshots this week—or many reports about just one topic. And those reports might not have explained where FDA was in our decision-making process. Here's a recap of some of our work this week, where we were listening, clarifying, leading, educating, and taking action, as we assess the science about the food and medical products you use on a daily basis.

 

Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 19 Sep 2008 14:02:37 -0500 (CDT)
Subject: Derringer Foodservices Issues Allergy Alert on Albacore Tuna Salad Hoagie (September 17)

Derringer Foodservices Issues Allergy Alert on Albacore Tuna Salad Hoagie (September 17)
Fri, 19 Sep 2008 13:31:00 -0500

This product is being recalled due to the omission of egg in the ingredient statement following the ingredient Reduced Calorie Mayonnaise. The recall decision was based on a potential allergen was included in the product and excluded from the label ingredient statement. This label omission was discovered in a standard ingredient statement audit.


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