Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 11 Sep 2008 07:56:59 -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: September 11, 2008 |
The following new items were added to the CDRH web pages on . Previous CDRH New Items can be found on the CDRHNew Page.
Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 11 Sep 2008 08:26:14 -0500 (CDT)
Subject: CDRH New Update (9/10/2008 Correction)
No new items were posted on September 10, 2008.
Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 11 Sep 2008 15:53:50 -0500 (CDT)
Subject: Medical Device Recalls: Physio Control, Inc. LifePak CR Plus Automated External Defibrillators (AEDs)
You are subscribed to Medical Device Recalls for U.S. Food & Drug Administration (FDA). Information about the Physio Control, Inc. LifePak CR Plus Automated External Defibrillators (AEDs) Class I Recall has recently been updated, and is now available.
Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 11 Sep 2008 15:58:37 -0500 (CDT)
Subject: CFSAN Constituent Update September 11, 2008
* U.S. Food and Drug Administration *
* Center for Food Safety and Applied Nutrition *
CONSTITUENT UPDATE
Constituent Updates are also available on the web at http://www.cfsan.fda.gov/~dms/cfsupdat.html.
September 11, 2008
FDA and Drug Information Association Sponsoring September Workshop on FDA Critical Path Initiative
The Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN) and the Drug Information Association (DIA) are reminding interested stakeholders about a September 15-16 workshop in Bethesda, Md., on FDA's Critical Path Initiative.
The Critical Path Initiative is an FDA effort to modernize the science and tools used in the development, evaluation, manufacture and use of FDA-regulated products. Workshop participants will learn what has been accomplished under the initiative, the status of current projects, and future activities regarding human and veterinary drugs, human biologics, medical devices, and foods.
Food-related sessions at the workshop will include:
- Food Allergen Thresholds: Applications and Data Gaps
- Quantitative Structure Activity Relationship Analysis and Chemoinformatics Meet Human Health Effects and Food Additives
- Positioning US FDA in the International Regulatory Initiatives via the Computational Toxicology Program in CFSAN
- Where Molecular Epidemiology and Microbial Forensics Meet for Food Safety
- Developing a Framework for Biomarker Qualification for Chronic Disease Risk
Breakout sessions will feature specialists from CFSAN as well as other FDA Centers. End-of-day roundtables will be led by FDA Center Directors.
For more information about workshop topics and sessions, and to register for the workshop, please visit http://www.diahome.org/DIAHome/resources/content.aspx?type=eopdf&file=%2fproductfiles%2f17181%2f08039%2Epdf, or contact Kathleen Donner at the Drug Information Association's office at 215-293-5810 or at Kathleen.Donner@diahome.org.
Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 11 Sep 2008 16:42:05 -0500 (CDT)
Subject: CDER New 9/10 & 11/2008
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September 11, 2008
- Drugs@FDA Downloadable Data Files (updated)
September 10, 2008
Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 11 Sep 2008 12:28:49 -0500 (CDT)
Subject: FDA MedWatch- Rituzan (rituximab)- Important New Safety Information Regarding Progressive Multifocal Leukoencephalopathy With The Use Of Rituxan
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Genentech informed healthcare professionals of revisions to prescribing information for Rituxan regarding a case of progressive multifocal leukoencephalopathy (PML) leading to death in a patient with rheumatoid arthritis who received Rituxan in a long-term safety extension clinical study. The patient developed a JC virus infection with resultant PML and death 18 months after taking the last dose of Rituxan. Healthcare professionals treating patients with Rituxan should consider PML in any patient presenting with new onset neurologic manifestations. Additionally, consultation with a neurologist, brain MRI and lumbar puncture should be considered as clinically indicated.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter and updated prescribing information for Rituxan regarding the above issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Rituxan
Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 11 Sep 2008 14:02:43 -0500 (CDT)
Subject: FDA: West Virginia Livestock Owner Sentenced in Criminal and Civil Contempt Case
FDA: West Virginia Livestock Owner Sentenced in Criminal and Civil Contempt Case
Thu, 11 Sep 2008 13:39:00 -0500
The U.S. Food and Drug Administration announced today that a West Virginia cattle dealer has been sentenced to six months probation for refusing to obey court orders in 2006 and 2008 that prohibited her from introducing animals into the food supply until the FDA had approved her record-keeping system. The FDA initiated the case after illegal levels of drug residue were found repeatedly in calves that Shirley A. Rhodes of Sandyville sold for use as human food.
Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 11 Sep 2008 14:07:18 -0500 (CDT)
Subject: FDA MedWatch- LifePak CR Plus Automated External Defibrillators- Class I Recall Because The Shock Button Is Not Visible Which Impedes Responder's Ability To Provide Shock Therapy
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Physio Control, Inc., issued a recall of LifePak CR Plus Automated External Defibrillators (AED), used by emergency or medical personnel to treat adults in cardiopulmonary arrest. The product was recalled because the AED instructs the responder by voice prompts to press the shock button which is not visible because it is covered, thereby making the responder unable to provide shock therapy. The AED device should be removed from service or the manufacturer-provided diagram should be consulted to remove and discard the shock button cover.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Recall Notice regarding this issue:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#LifePakCR
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