From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 16 Jul 2008 08:06:44 -0500 (CDT)
Subject: Good Clinical Practice Update (July 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 the "In the News" section of the Good Clinical Practice Program's home page:
1) FDA announces availability of documents from the Global Harmonization Task Force (GHTF)
2) FDA/DIA Critical Path Initiative Program to be held September 15-16, 2008
You can obtain more information about these items by visiting www.fda.gov/oc/gcp
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 16 Jul 2008 08:29:45 -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.
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 16 Jul 2008 11:45:28 -0500 (CDT)
Subject: CDER New 7/15/2008
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July 15, 2008
- CDER Organization Charts [HTML] [PDF] (updated)
- Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
- New and Generic Drug Approvals
- Levoleucovorin (levoleucovorin calcium) I.V. Powder, Spectrum Pharmaceuticals, Inc., Labeling Revision
- Prandin (repaglinide) Tablets, Novo Nordisk, Inc., Labeling Revision
- Synthroid (levothyroxine sodium) Tablets, Abbott Laboratories, Labeling Revision
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 16 Jul 2008 14:05:09 -0500 (CDT)
Subject: FDA MedWatch- MedWatch-Sodium Polystyrene Sulfonate Suspension-Recall Of 2 Lots Of Product Due To The Presence Of Yeast Which Could Affect Immunocompromised Patients
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Roxane Laboratories, Inc. informed healthcare professionals of the recall of two lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; lot 856396A Exp April 2010, and lot 856693A Exp May 2010), a product used to treat hyperkalemia. A sample of one of the affected lots tested positive for a strain of yeast, which could potentially affect immunocompromised patients. Symptoms of a yeast infection range from thrush, skin rash, and blood infections. If patients develop an infection they should consult their physician. Pharmacists should determine if any of the referenced product has been dispensed and retrieve it. Additionally, pharmacists and wholesalers of the product should discontinue distribution and use of the referenced lots immediately and contact the manufacturer regarding returning the product.
See the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's recall notice regarding this issue at:
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 16 Jul 2008 14:12:57 -0500 (CDT)
Subject: FDA MedWatch -Electronic Medical Devices- Possible Malfunction Caused By Computed Tomography (CT) Scanning
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FDA informed healthcare professionals of the possibility that x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction. Most patients with electronic medical devices undergo CT scans without any adverse consequences. However, the Agency has received a small number of reports of adverse events in which CT scans may have interfered with electronic medical devices, including pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug infusion pumps. FDA is continuing to investigate the issue and is working with the manufacturer to raise awareness in the healthcare community. See the FDA Public Health Notification for a description of adverse event reports and recommendations regarding reducing the potential risk to patients.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Public Health Notification regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#ElectronicMedical
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