From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 17 Jul 2008 10:03:22 -0500 (CDT)
Subject: FDA Reaches Settlement with California Hearing Device Maker
FDA Reaches Settlement with California Hearing Device Maker
Thu, 17 Jul 2008 09:06:00 -0500
The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and CEO Jeffrey Greiner over alleged violations of federal law.
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 17 Jul 2008 10:26:28 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: July 17, 2008 |
The following new items were added to the CDRH web pages on July 16, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Summary Information for: EVOLENCE® Collagen Filler |  | |
| Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Bone Sonometers |  | |
| Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, July 15, 2008 - Agenda, Roster, Briefing, Questions, Brief Summary | | |
| PMA Final Decisions for June 2008 | |
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 17 Jul 2008 15:03:44 -0500 (CDT)
Subject: FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals
FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals
Thu, 17 Jul 2008 14:13:00 -0500
The U.S. Food and Drug Administration (FDA) today announced it is launching a two-year fellowship program aimed at attracting scientists, engineers and health professionals to the agency.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 17 Jul 2008 15:10:23 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Recalls, Withdrawals, Field Corrections & Notifications Update
You are subscribed to CBER's Recalls, Withdrawals, Field Corrections & Notifications for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Medical Device Notification (PSN-08-05) - Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc.
Posted: 7/17/2008; Notification Date: 6/24/2008
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 17 Jul 2008 18:44:26 -0500 (CDT)
Subject: FDA Data Standards Update - SPL eReg/eList Part 11 Docket Memo & Revised SPL Stylesheet
Greetings,
The FDA Data Standards Council's SPL web page (http://www.fda.gov/oc/datacouncil/spl.html) was updated Thursday, July 17, 2008, to include the following information:
SPL - Drug Establishment Registration and Drug Listing Docket Memo: http://www.fda.gov/oc/datacouncil/drug_electronic_reg_list_docket_memo.pdf
Revised SPL Release Four Stylesheet (v4.01)
Lonnie Smith
Project Manager
Structured Product Labeling Team
Medical Informatics Staff &
FDA Data Standards Council
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 17 Jul 2008 19:02:51 -0500 (CDT)
Subject: FDA Lifts Warning About Eating Certain Types of Tomatoes
FDA Lifts Warning About Eating Certain Types of Tomatoes
Tue, 17 Jun 2008 18:46:00 -0500
After a lengthy investigation, the FDA has determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency is removing its June 7 warning against eating certain types of red raw tomatoes.
Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 18 Jul 2008 08:02:48 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index | | |
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| Date: July 18, 2008 |
The following new items were added to the CDRH web pages on July 17, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
| FDA / NHLBI / NSF Workshop on Computer Methods for Cardiovascular Devices, March 18-19, 2008 (Video Added) | |
Update: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 18 Jul 2008 16:05:11 -0500 (CDT)
Subject: Making Sense of Vytorin Concerns
Making Sense of Vytorin Concerns
Fri, 18 Jul 2008 15:12:00 -0500
This article clarifies the results of a study that was published in the New England Journal of Medicine, and emphasizes the importance of continuing on prescribed cholesterol medications.
Update: 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 18 Jul 2008 16:05:28 -0500 (CDT)
Subject: Living with Fibromyalgia, Drugs Approved to Manage Pain
Living with Fibromyalgia, Drugs Approved to Manage Pain
Fri, 18 Jul 2008 15:12:00 -0500
A second drug has been approved to treat fibromyalgia, a painful chronic condition that affects the muscles and joints.
Update: 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 17 Jul 2008 15:22:14 -0500 (CDT)
Subject: MedWatch - Micro-bubble Contrast Agents (Definity, Optison): changes to Boxed Warnings, Warnings and Contraindications
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FDA is updating healthcare professionals about recent changes made to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information for micro-bubble contrast agents, a sterile suspension of perflutren gas microspheres, indicated for use in certain patients with suboptimal echocardiograms, to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
These changes reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007. The revised Boxed Warning and Warnings highlight the risk of serious cardiopulmonary reactions during or within 30 minutes following the administration of these products and recommend that high risk patients with pulmonary hypertension or unstable cardiopulmonary conditions be closely monitored during and for at least 30 minutes post administration of these contrast agents. In addition, several of the Contraindications that were added to the labeling in October, 2007 were removed because FDA determined that, in some patients, the benefits from the diagnostic information obtained through the use of Definity or Optison may outweigh the risk for serious cardiopulmonary reactions, even among some patients at particularly high risk for these reactions.
Read the complete MedWatch 2008 safety summary, including links to the Information for Healthcare Professionals and previous MedWatch alerts, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Microbubble
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