Update: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 18 Aug 2008 09:02:38 -0500 (CDT)
Subject: FDA Data Standards Update - Terminology Update & HL7 SPL WG Contact Change
Greetings,
The FDA Data Standards Council's SPL web page (http://www.fda.gov/oc/datacouncil/spl.html) was updated Monday, August 18, 2008, to update the following information:
- Correction to solid oral dosage form list in Additional Validation files
- Change to contact information for HL7 SPL Working Group
- Removal of outdated SPL presentations
Lonnie Smith
Project Manager
Structured Product Labeling Team
Medical Informatics Staff &
FDA Data Standards Council
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 18 Aug 2008 09:03:42 -0500 (CDT)
Subject: Manufacturer for Publix Brand Vanilla Wafers Issues a Recall for Undeclared Soy (August 15)
Manufacturer for Publix Brand Vanilla Wafers Issues a Recall for Undeclared Soy (August 15)
Mon, 18 Aug 2008 08:18:00 -0500
The manufacturer of Publix Vanilla Wafers is recalling a limited number of 12oz boxes of Vanilla Wafers with a code date of 030409A as they may contain undeclared soy. Persons who have an allergy to soy run the risk of a serious or possible life-threatening allergic reaction if they consume the affected product. The UPC number may be found on the side label below the Nutrition Facts panel: Publix Vanilla Wafers, UPC: 41415-00609
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 18 Aug 2008 11:23:44 -0500 (CDT)
Subject: FDA Data Standards Update - SPL Xforms Update
Greetings,
The SPL xforms have been updated to version 0.71. The web site containing the SPL xforms are accessible via a hyperlink on this web page: http://www.fda.gov/oc/datacouncil/xforms.html.
Lonnie Smith
Project Manager
Structured Product Labeling Team
Medical Informatics Staff &
FDA Data Standards Council
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 18 Aug 2008 13:11:22 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Substantially Equivalent 510(k) Device - Cymbal Automated Blood Collection System - Haemonetics Corp
Posted: 8/18/2008, Clearance Date: 8/15/2008
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 18 Aug 2008 13:51:00 -0500 (CDT)
Subject: FDA MedWatch - Byetta (exenatide) - Reports of 6 cases of hemorrhagic or necrotizing pancreatitis since October 2007
Since issuing Information for Healthcare Professionals in October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.
Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.
Read the complete MedWatch 2008 Safety Summary, including a link to the '"Information for Healthcare Professionals" page, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Byetta
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
