Thursday, May 22, 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: Wed, 21 May 2008 07:51:44 -0500 (CDT)
Subject: CDRH New Update

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CDRHNEW Logo Date: May 21, 2008

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

* FDA Workshop: Exploration of Public Policy Development Regarding the Study and Analysis of Sex Differences in the Clinical Evaluation of Cardiovascular Medical Products, June 2, 2008 Text
* Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays; Availability. Text PDF
* Federal Register: Medical Devices; Immunology and Microbiology Devices; Classification of 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: Wed, 21 May 2008 08:36:39 -0500 (CDT)
Subject: FDA Warning Letters Update

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