Thursday, April 24, 2008

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

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 23 Apr 2008 06:00:17 -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?
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CDRHNEW Logo Date: April 23, 2008

The following new items were added to the CDRH web pages on April 22, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

* Federal Register: Agency Information Collection Activites; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking. Text PDF

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 23 Apr 2008 08:24:39 -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.


Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 23 Apr 2008 11:07:41 -0500 (CDT)
Subject: FDA Clears Glove Made from New Type of Latex

FDA Clears Glove Made from New Type of Latex
Wed, 23 Apr 2008 11:15:00 -0500

The U.S. Food and Drug Administration has cleared for marketing the first device made from a new form of natural rubber latex, guayule latex. The product, the Yulex Patient Examination Glove, is derived from the guayule bush, a desert plant native to the Southwestern United States.


Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 23 Apr 2008 16:05:54 -0500 (CDT)
Subject: DPH Issues Consumer Warning for Chang Farm Soy Sprouts Because of Bacteria Contamination (April 23)

DPH Issues Consumer Warning for Chang Farm Soy Sprouts Because of Bacteria Contamination (April 23)
Wed, 23 Apr 2008 16:44:00 -0500

The Department of Public Health (DPH) is issuing a warning to the public not to consume any soy sprouts produced from Chang Farms in Whatley, Massachusetts because of the presence of bacteria called Listeria monocytogenes (L. monocytogenes).


Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 23 Apr 2008 18:05:43 -0500 (CDT)
Subject: FDA Strengthens Safeguards for Consumers of Beef

FDA Strengthens Safeguards for Consumers of Beef
Wed, 23 Apr 2008 17:08:00 -0500

The U.S. Food and Drug Administration today issued a final regulation barring certain cattle materials from all animal feed, including pet food. The final rule further protects animals and consumers against bovine spongiform encephalopathy (BSE, also known as "mad cow disease").


Message: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 23 Apr 2008 19:10:35 -0500 (CDT)
Subject: Allergy Alert on Undeclared Dairy in 11-Ounce Single Serve Silk Soymilk Chocolate Flavor in Plastic Bottles (April 23)

Allergy Alert on Undeclared Dairy in 11-Ounce Single Serve Silk Soymilk Chocolate Flavor in Plastic Bottles (April 23)
Wed, 23 Apr 2008 18:35:00 -0500

WhiteWave Foods Company is voluntarily recalling 11-ounce plastic single serve bottles of Silk Soymilk Chocolate Flavor because it may contain undeclared milk protein.


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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

Wednesday, April 23, 2008

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 22 Apr 2008 13:05:25 -0500 (CDT)
Subject: FDA Approves Cimzia to Treat Crohn's Disease

FDA Approves Cimzia to Treat Crohn's Disease
Tue, 22 Apr 2008 12:25:00 -0500

A new drug has been approved to help sufferers of Crohn's disease, the U.S. Food and Drug Administration announced today. Cimzia (certolizumab pegol) received approval for adults with moderate to severe Crohn's disease who have not responded to conventional therapies.


Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 22 Apr 2008 13:05:29 -0500 (CDT)
Subject: Fine Land Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Dried Snow Fungus (April 8)

Fine Land Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Dried Snow Fungus (April 8)
Tue, 22 Apr 2008 12:14:00 -0500

Fine Land Corp, 239 Bay 20th Street Brooklyn NY 11214, is recalling its Ying Feng Foodstuffs brand dried snow fungus because it contains undeclared sulfites.


Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 22 Apr 2008 13:07:36 -0500 (CDT)
Subject: Fine Land Corp Issues Alert on Undeclared Sulfites in Golden Girl Brand "Mut Gung" Sweetened Ginger (April 8)

Fine Land Corp Issues Alert on Undeclared Sulfites in Golden Girl Brand "Mut Gung" Sweetened Ginger (April 8)
Tue, 22 Apr 2008 12:14:00 -0500

Fine Land Corp, 239 Bay 20th Street, Brooklyn, NY 11214 is recalling its Golden Girl brand "Mut Gung" sweetened ginger because it contains undeclared sulfites.


Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 22 Apr 2008 13:08:06 -0500 (CDT)
Subject: Fine Land Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Dried Bulbus Lily (April 11)

Fine Land Corp Issues Alert on Undeclared Sulfites in Ying Feng Foodstuffs Brand Dried Bulbus Lily (April 11)
Tue, 22 Apr 2008 12:14:00 -0500

Fine Land Corp, 239 Bay 20th Street Brooklyn NY 11214, is recalling its Ying Feng Foodstuffs brand Dried Bulbus Lily because it contains undeclared sulfites.


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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

Tuesday, April 22, 2008

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 21 Apr 2008 06:02:12 -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?
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CDRHNEW Logo Date: April 21, 2008

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

* Federal Register: Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance With Section 402(j) Text PDF
* Guidance for Industry and FDA Staff: Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions Text PDF
* Guidance for Industry and FDA Staff: Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis Text PDF
* Guidance for Industry and FDA Staff: Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs Text PDF

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 21 Apr 2008 09:05:03 -0500 (CDT)
Subject: KFC Issues a Nationwide Allergy Alert, Recalls Unlabeled Double Chocolate Chip Cakes (April 18)

KFC Issues a Nationwide Allergy Alert, Recalls Unlabeled Double Chocolate Chip Cakes (April 18)
Mon, 21 Apr 2008 08:33:00 -0500

KFC Corporation is voluntarily recalling its Double Chocolate Chip Cakes because they contain eggs, milk, wheat, soy ingredients and possibly traces of tree nuts, and are not individually labeled with ingredient information.


Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 21 Apr 2008 16:07:20 -0500 (CDT)
Subject: FDA Approves First Compact Heart Assist Device

FDA Approves First Compact Heart Assist Device
Mon, 21 Apr 2008 16:03:00 -0500

The U.S. Food and Drug Administration today approved a heart assist device with a novel design that is the first to mechanically support the weakened heart of a small-sized adult man or woman with heart failure who is at risk of dying while awaiting a heart transplant.


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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

Saturday, April 19, 2008

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

You have requested to receive a Daily Digest e-mail from U.S. Food & Drug Administration (FDA).

Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 18 Apr 2008 06:08:58 -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?
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CDRHNEW Logo Date: April 18, 2008

The following new items were added to the CDRH web pages on April 17, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

* Consumer Information on: Talent™ Abdominal Stent Graft System - P070027 Text

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 18 Apr 2008 15:06:00 -0500 (CDT)
Subject: California Department of Public Health Warns Consumers Not to Eat Chaca Chaca Chacatrozo Candy Imported from Mexico (April 17)

California Department of Public Health Warns Consumers Not to Eat Chaca Chaca Chacatrozo Candy Imported from Mexico (April 17)
Fri, 18 Apr 2008 14:51:00 -0500

Dr. Mark Horton, director of the California Department of Public Health (CDPH), today warned consumers not to eat Chaca Chaca Chacatrozo candy imported from Mexico after tests by CDPH found levels of lead that could cause health problems.


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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420