Saturday, May 10, 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: Fri, 9 May 2008 06:41:59 -0500 (CDT)
Subject: CDRH New Update

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CDRHNEW Logo Date: May 9, 2008

The following new items were added to the CDRH web pages on May 8, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

* Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Slides Text
* PMA Final Decisions for April 2008 Text

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 9 May 2008 10:26:07 -0500 (CDT)
Subject: FDA Warning Letters Update

You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.


Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 9 May 2008 11:03:41 -0500 (CDT)
Subject: FDA Approves First Generic Ropinirole

FDA Approves First Generic Ropinirole
Fri, 09 May 2008 10:56:00 -0500

The U.S. Food and Drug Administration has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.


Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 9 May 2008 14:05:12 -0500 (CDT)
Subject: FDA Approves New Formulation of Coagulation Therapy

FDA Approves New Formulation of Coagulation Therapy
Fri, 09 May 2008 14:23:00 -0500

he U.S. Food and Drug Administration has approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 81 degrees Fahrenheit) for up to two years.


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