Monday, April 14, 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: Fri, 11 Apr 2008 05:53:30 -0500 (CDT)
Subject: CDRH New Update

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CDRHNEW Logo Date: April 11, 2008

The following new items were added to the CDRH web pages on April 10, 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; Medical Device User Fee Amendments of 2007; Foreign Small Business Qualification Certification, Form FDA 3602A. Text PDF
* FDA & YOU - News for Health Educators and Students - Spring 2008 Text
* Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Waivers for Conflicts of Interest Text
* Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, July 17, 2007 - Minutes Text
* Radiological Devices Panel Advisory Meeting, March 4-5, 2008 - Minutes Text

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 11 Apr 2008 08:07:30 -0500 (CDT)
Subject: Herbal Science International, Inc. Recalls Twelve Dietary Herbal Supplements Nationwide Because of Possible Health Risk Associated with Ephedra, Aristolochic Acid and Human Placenta (April 10)

Herbal Science International, Inc. Recalls Twelve Dietary Herbal Supplements Nationwide Because of Possible Health Risk Associated with Ephedra, Aristolochic Acid and Human Placenta (April 10)
Fri, 11 Apr 2008 07:49:00 -0500

Herbal Science International, Inc. (AKA Jen-On Herbal Science International, Inc.) is recalling twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers.


Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 11 Apr 2008 11:10:39 -0500 (CDT)
Subject: Recent Device Approvals: CONTAK RENEWAL® 3 AVT® Cardiac Resynchronization Defibrillator (CRT-D)

You are subscribed to Recent Device Approvals updates for U.S. Food & Drug Administration (FDA). Information about the CONTAK RENEWAL® 3 AVT® Cardiac Resynchronization Defibrillator (CRT-D), Models M150, M155, M157, and M159 has recently been posted to the FDA website, and is now available.


Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Sat, 12 Apr 2008 14:06:00 -0500 (CDT)
Subject: Salmonella Illnesses in Multiple States may be Linked to Recently Recalled Cereal

Salmonella Illnesses in Multiple States may be Linked to Recently Recalled Cereal
Sat, 12 Apr 2008 13:40:00 -0500

The recalled products were distributed nationally under the Malt-O-Meal brand name as well as under private label brands including Acme, America's Choice, Food Club, Giant, Hannaford, Jewel, Laura Lynn, Pathmark, Shaw's, ShopRite, Tops and Weis Quality. The cereals have "Best If Used By" dates from April 8, 2008 (coded as "APR0808") through March 18, 2009 (coded as "MAR1809").


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