Wednesday, April 30, 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: Tue, 29 Apr 2008 05:46:14 -0500 (CDT)
Subject: CDRH New Update

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CDRHNEW Logo Date: April 29, 2008

The following new items were added to the CDRH web pages on April 28, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

* Federal Register: Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Reopening of Comment Period. Text PDF

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Apr 2008 08:05:11 -0500 (CDT)
Subject: Coronary Artery Plaque Imaging Device Cleared by FDA

Coronary Artery Plaque Imaging Device Cleared by FDA
Tue, 29 Apr 2008 07:42:00 -0500

The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the coronary arteries.


Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Apr 2008 18:04:32 -0500 (CDT)
Subject: FDA Approves Amitiza for IBS-C

FDA Approves Amitiza for IBS-C
Tue, 29 Apr 2008 17:45:00 -0500

The U.S. Food and Drug Administration has approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over.


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