U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Apr 2008 05:46:14 -0500 (CDT)
Subject: CDRH New Update

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

Date: April 29, 2008

The following new items were added to the CDRH web pages on April 28, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Federal Register: Dental Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury and Reclassification of Dental Mercury; Issuance of Special Controls for Amalgam Alloy; Reopening of Comment Period.

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Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Apr 2008 07:08:21 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Proposed and Final Rules Update

You are subscribed to CBER's Proposed and Final Rules for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

FEDERAL REGISTER: Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application; Final Rule - 4/29/2008

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Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Apr 2008 07:35:09 -0500 (CDT)
Subject: Good Clinical Practice Update (April 29, 2008)

You are a subscriber to the Good Clinical Practice/ Human Subject Protection e-mail update service provided by the U.S. Food & Drug Administration (FDA). The following information was recently added to our home page under the "In the News" section:

--> The Federal Register publication on foreign clinical studies not conducted under an investigational new drug application (21 CFR 312.120) <---

You can find this information at www.fda.gov/oc/gcp .

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Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Apr 2008 08:05:11 -0500 (CDT)
Subject: Coronary Artery Plaque Imaging Device Cleared by FDA

Coronary Artery Plaque Imaging Device Cleared by FDA
Tue, 29 Apr 2008 07:42:00 -0500

The U.S. Food and Drug Administration has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the coronary arteries.

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Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Apr 2008 09:32:41 -0500 (CDT)
Subject: FDA Data Standards Update - SPL Terminology Update: Business Operations

Greetings,

The FDA Data Standards Council's SPL web page was updated yesterday, Monday, April 28, 2008, to replace the term and code for "importer" and add these new terms and codes:

IMPORT C73599

RELABEL C73607

REPACK C73606

The new terms and codes are located on this web page: http://www.fda.gov/oc/datacouncil/term.html#busop

.

Lonnie Smith

Project Manager

Food and Drug Administration

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Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Tue, 29 Apr 2008 18:04:32 -0500 (CDT)
Subject: FDA Approves Amitiza for IBS-C

FDA Approves Amitiza for IBS-C
Tue, 29 Apr 2008 17:45:00 -0500

The U.S. Food and Drug Administration has approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over.

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