Thursday, June 26, 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, 25 Jun 2008 07:48:04 -0500 (CDT)
Subject: Oncology Drugs Update: Velcade (bortezomib) is Approved for Initial Treatment of Patients with Multiple Myeloma

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Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

Velcade (bortezomib) is approved for initial treatment of patients with multiple myeloma.
More information: http://www.fda.gov/cder/offices/oodp/whatsnew/bortezomib2008.htm

 


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Tuesday, June 3, 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: Mon, 2 Jun 2008 11:04:38 -0500 (CDT)
Subject: The June 2008 MedSun Newsletter is now available...

Medical Product Safety Network

Please note a new audioconference entitled, “The Practice of Laboratory Medicine in the Twenty First Century – Achieving Relevance in a Tidal Wave of Change has been added to the Educational Materials section.

 

 

Highlighted articles include:

 

Concerns with Heparin

The recent serious injuries and deaths associated with the use of potentially contaminated heparin are of great interest at this time. The following links contain information about the ongoing heparin issue...

 

Large, Single-Center, Single-Operator Experience with Transvenous Lead Extraction: Outcomes and Changing Indications

Examining contemporary indications, outcomes, and complications of transvenous lead extraction in a large series of patients at a high-volume lead extraction center...

 

Complexity of MRI Induced Heating on Metallic Leads: Experimental Measurements of 374 Configurations

Findings highlight the factors that have significant effects on MRI induced heating of implanted wires and lead…

 

Design of the Pacemaker Remote Follow-up Evaluation and Review (PREFER) Trial to Assess the Clinical Value of the Remote Pacemaker Interrogation in the Management of Pacemaker Patients

Although pacemakers are primarily used for the treatment of bradycardia, diagnostic data available in current pacemakers allow them to be also used as sophisticated, continuous monitoring devices...

 

Prevent Pediatric Medication Errors

The Joint Commission’s latest Sentinel Event Alert addresses pediatric medication errors, and urges greater attention to precautions such as medication standardization, improved medication identification and communication techniques...

 

Development, Testing, and Findings of a Pediatric-Focused Trigger Tool to Identify Medication-Related Harm in U.S. Children’s Hospitals

Adverse drug event rates in hospitalized children are substantially higher than previously described...

 

Recognizing the Sources of Interference with Immunoassays

Therapeutic drug monitoring (TDM) has improved patient care but studies suggest that improvements can be made...

 

2008 National Patient Safety Goals Laboratory Services Program

The Joint Commission article lists laboratory program safety goals for 2008...

 

Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product

Some glucose meter test strips that use glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) methodology may overestimate measurements when blood maltose levels exceed certain levels...

 

Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations

The objective of the CLIA program is to ensure quality laboratory testing...

     

You are subscribed to the MedSun Website, part of U.S. Food & Drug Administration (FDA).

The content on the Homepage has been updated to reflect this month's Newsletter items.  This information can be viewed by clicking here

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

 
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