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, 12 Jun 2008 06:35:07 -0500 (CDT)
Subject: CDRH New Update

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

Date: June 12, 2008

The following new items were added to the CDRH web pages on June 11, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Ophthalmic Devices Panel Advisory Meeting, June 10, 2008 - Agenda, Roster, Briefing, Questions, Brief Summary

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 12 Jun 2008 08:03:51 -0500 (CDT)
Subject: Updated Press Release: Lake Country and LAND O LAKES Lamb Feed Voluntary Recall

Updated Press Release: Lake Country and LAND O LAKES Lamb Feed Voluntary Recall
Thu, 12 Jun 2008 07:25:00 -0500

The Land O'Lakes Purina Feed plant in Fremont, Neb., has initiated a limited voluntary recall of four lamb feed products, packaged in 50-pound bags, due to the potential for higher than acceptable levels of copper.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 12 Jun 2008 13:04:18 -0500 (CDT)
Subject: FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety

FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety
Thu, 12 Jun 2008 12:14:00 -0500

In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity.

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Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 12 Jun 2008 12:22:45 -0500 (CDT)
Subject: FDA MedWatch -Spring Issue Of The FDA Drug Safety Newsletter Is Now Available

The Drug Safety Newsletter is a FDA publication for healthcare professionals and the medical community.  The newsletter provides information on the findings of selected postmarketing drug safety reviews from FDA’s Center for Drug Evaluation and Research.  The newsletter also provides information on important emerging drug safety issues and recently approved new molecular entities.  FDA hopes the newsletter will raise awareness of reported adverse events, and stimulate additional adverse event reporting by healthcare professionals. 

 

Read the entire 2008 MedWatch Safety Summary, including a link to the Drug Safety Newsletter at:

 

http://www.fda.gov/cder/dsn/default.htm

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