Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 07:02:48 -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: October 10, 2008 |
The following new items were added to the CDRH web pages on October 9, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recall Regulations |  |  |
Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 07:46:49 -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.
Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products - 10/9/2008
Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 11:20:08 -0500 (CDT)
Subject: CFSAN Constituent Update October 10, 2008
* U.S. Food and Drug Administration * CONSTITUENT UPDATE Constituent Updates are also available on the web at http://www.cfsan.fda.gov/~dms/cfsupdat.html.
* Center for Food Safety and Applied Nutrition *
Announcing Availability of the new Employees FIRST Food Defense Awareness Training Kit for First-Line Employees
The U.S. Food and Drug Administration (FDA) in collaboration with the Center for Disease Control (CDC) and U.S. Department of Agriculture (USDA) will launch its food defense awareness training kit for First-Line Employees in the food and agriculture industry from farm to table. The FIRST training kit is the second in a line of Food Defense Awareness Materials. ALERT, a program that was issued in July 2006, also focuses on prevention and identifies key points that supervisors and managers in industry and businesses can use to raise awareness of food defense issues and decrease the risks of intention food contamination.
Employees FIRST is a food defense awareness initiative for employees that food industry management can include in their ongoing food defense training programs. FIRST will educate front-line industry workers from farm to table about the risk of intentional food contamination and the actions they can take to identify and reduce risks including:
F – FOLLOW company food defense plan and procedures
I – INSPECT your work area and surrounding areas
R – RECOGNIZE anything out of the ordinary
S – SECURE all ingredients, supplies and finished product
T – TELL management if you notice anything unusual or suspicious
Availability of Kit: Single copies of the kit will be available in English and Spanish. The kit is packaged in a self-mailer and it includes: 1 DVD; 4-color front and back poster in English and Spanish; and on-screen instructions for use. In addition, a web-ready version will be made available late October 2008. Copies of the kit may be obtained by ordering online from the Food Defense & Terrorism website (http://www.cfsan.fda.gov/fooddefense) or an email to marion.allen@fda.hhs.gov.
Contact: Marion V. Allen, Center for Food Safety and Applied Nutrition, Food Defense Oversight Team (HFS-007), Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: (301) 436-1584, email: marion.allen@fda.hhs.gov.
Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 14:08:40 -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: Antihemophilic Factor (Recombinant) Kogenate FS - Bayer HealthCare LLC.
Posted: 10/10/2008, Approval Date: 10/10/2008
Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 14:51:49 -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.
FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A
Posted: 10/10/2008
Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 15:03:17 -0500 (CDT)
Subject: FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland
FDA Approves Rapaflo for the Treatment of Symptoms Due to an Enlarged Prostate Gland
Fri, 10 Oct 2008 14:44:00 -0500
The U.S. Food and Drug Administration today approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate.
Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 16:38:02 -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.
Approval Information: C1 Esterase Inhibitor (Human) (CINRYZE) - Lev Pharmaceuticals, Inc.
Posted: 10/10/2008, Approval Date: 10/10/2008
FDA Licenses for Marketing New Therapy for Rare Genetic Disease
Posted: 10/10/2008
Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 08:02:48 -0500 (CDT)
Subject: Russell Stover Candies, Inc. Issues Hazelnut Allergy Alert for the 2 7/8 Oz Size Of Private Reserve Assorted Chocolates (October 9)
Russell Stover Candies, Inc. Issues Hazelnut Allergy Alert for the 2 7/8 Oz Size Of Private Reserve Assorted Chocolates (October 9)
Fri, 10 Oct 2008 07:40:00 -0500
The recalled product was distributed in the following states and cities: Texas, California, Louisiana, North Carolina, South Carolina, Virginia, Tennessee; Southaven, Mississippi; Billings, Montana; Sparks, Nevada; and Madison Heights, Michigan. An investigation determined 29 boxes of this candy may have been purchased by consumers, and up to another 188 boxes may have reached retail store locations. All the retail stores have been contacted to have the suspected product removed from the shelves.
Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 12:03:38 -0500 (CDT)
Subject: FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A
FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A
Fri, 10 Oct 2008 11:51:00 -0500
The U.S. Food and Drug Administration today approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with the most severe form of hemophilia.
Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 14:03:15 -0500 (CDT)
Subject: Enforcement Report for October 8, 2008
Enforcement Report for October 8, 2008
Fri, 10 Oct 2008 12:52:00 -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.
Update : 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 15:03:15 -0500 (CDT)
Subject: FDA Launches Food Defense Awareness Training Kit for Employees in the Food Industry
FDA Launches Food Defense Awareness Training Kit for Employees in the Food Industry
Fri, 10 Oct 2008 14:44:00 -0500
Today the U.S. Food and Drug Administration in collaboration with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture launched its food defense awareness training kit for first line food industry employees. The training targets these individuals because they can play an important role in helping to keep our nation's food supply safe, from the farm to the table.
Update : 12
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 10 Oct 2008 17:03:09 -0500 (CDT)
Subject: FDA Licenses for Marketing New Therapy for Rare Genetic Disease
FDA Licenses for Marketing New Therapy for Rare Genetic Disease
Fri, 10 Oct 2008 16:05:00 -0500
The U.S. Food and Drug Administration today licensed for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. HAE affects about 6,000 to 10,000 individuals in the United States.
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