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: Thu, 21 Feb 2008 06:02:35 -0600 (CST)
Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

Date: February 21, 2008

The following new items were added to the CDRH web pages on February 20, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

	Federal Register: Draft Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices; Availability.
	PMA Final Decisions for January 2008

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 21 Feb 2008 13:05:13 -0600 (CST)
Subject: FDA Licenses New Hemophilia Treatment

FDA Licenses New Hemophilia Treatment
Thu, 21 Feb 2008 11:09:00 -0600

The new treatment, called Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free, is a genetically engineered version of factor VIII, a protein essential for the clotting of blood. Factor VIII, known as an anti-hemophilic factor, is missing or decreased in patients with hemophilia A.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 21 Feb 2008 13:05:15 -0600 (CST)
Subject: Pierre's Ice Cream Company Issues Allergy Alert on its Homestyle Brand of Dutch Chocolate Ice Cream for Undeclared Peanut Butter Cup Candies (Feb. 20)

Pierre's Ice Cream Company Issues Allergy Alert on its Homestyle Brand of Dutch Chocolate Ice Cream for Undeclared Peanut Butter Cup Candies (Feb. 20)
Thu, 21 Feb 2008 11:58:00 -0600

This ice cream was distributed in Ohio, Michigan, Western Pennsylvania, and Indiana and reached consumers through retail stores. The packaging does not reveal the presence of peanut butter candy or peanuts on the ingredient label. If consumers have a Dutch Chocolate 56 fl oz (purple package) with the code 07320 on the rim of the lid, they should discard the ice cream and send the lid of the empty container back to Pierre’s for a full refund.

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