Wednesday, May 21, 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, 20 May 2008 07:42:36 -0500 (CDT)
Subject: CDRH New Update

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CDRHNEW Logo Date: May 20, 2008

The following new items were added to the CDRH web pages on May 19, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

* Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays Text PDF

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 20 May 2008 18:17:54 -0500 (CDT)
Subject: FDA Approves Entereg to Help Restore Bowel Function Following Surgery

FDA Approves Entereg to Help Restore Bowel Function Following Surgery
Tue, 20 May 2008 16:35:00 -0500

The U.S. Food and Drug Administration approved Entereg (alvimopan) today to accelerate the restoration of normal bowel function in patients 18 years and up who have undergone partial large or small bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses.


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