From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 31 Jul 2008 08:13:29 -0500 (CDT)
Subject: Mammography What's New Update
You are subscribed to Mammography What's New for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
New Software Upgrades Under Amended Alternative Standard #6
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 31 Jul 2008 09:03:40 -0500 (CDT)
Subject: FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample
FDA Clears Test that Helps Identify Type of Cancer in Tumor Sample
Thu, 31 Jul 2008 08:38:00 -0500
The U.S. Food and Drug Administration has cleared for marketing a test that can help health care professionals determine what type of cancer cells are present in a malignant tumor. The Pathwork Tissue of Origin test compares the genetic material of a patient's tumor with genetic information on malignant tumor types stored in a database.
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 31 Jul 2008 12:19:07 -0500 (CDT)
Subject: The August 2008 MedSun Newsletter is now available...
Medical Product Safety Network
Please note: new KidNet items have been added to the Educational Materials section. KidNet focuses on identifying, understanding, and solving problems with medical devices used in neonatal and pediatric intensive care units. To view new items please visit these links:
MedSun KidNet Roundtable Discussion - held May 15, 2008
MedSun KidNet Roundtable Discussion - held October 15, 2007
Highlighted articles include:
Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion
This FDA public health notification describes serious adverse events associated with the use of recombinant human Bone Morphogenetic Progrein (rhBMP) in cervical spine fusion. These products are not approved by FDA for this use…
Does the Type of Out-of-Hospital Airway Interfere with Other Cardiopulmonary Resuscitation Tasks?
Out-of-hospital rescuers often perform tracheal intubation (TI) prior to other cardiopulmonary resuscitation (CPR) interventions. TI is a complex and error-prone procedure that may interfere with other key resuscitation tasks...
Prevention of Inadvertent Perioperative Hypothermia
Dangers Associated With Shared Multidose Vials
Research shows that up to 25% of healthcare practitioners re-enter vials with needles just injected into patients. Routinely re-entering vials with used needles and reusing syringes is placing patients at risk for infection from contamination...
Inadvertent Retention of Angled Drill Guides After Volar Locking Plate Fixation of Distal Radial Fractures: A Report of Three Cases
Advances in locking plate technology have proven especially valuable for fixation of distal radial fractures, and preliminary results have been excellent. However, new technology can sometimes lead to new complications...
ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: Executive Summary
This article contains the 2008 Guidelines from the ACC/AHA/HRS executive summary on device-based therapy of cardiac rhythm abnormalities...
Problems with Implantable Cardiac Device Therapy
ICD generators and leads are more prone to failures than are pacing systems alone; management of patients potentially dependent on "recalled" devices to deliver life-saving therapy is a particularly complex issue...
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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Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 31 Jul 2008 15:42:35 -0500 (CDT)
Subject: CFSAN Constituent Update July 30, 2008
* U.S. Food and Drug Administration * CONSTITUENT UPDATE Constituent Updates are also available on the web at http://www.cfsan.fda.gov/~dms/cfsupdat.html.
* Center for Food Safety and Applied Nutrition *
Due to several recent inquiries, we are resending this Constituent Update and including a link to the Federal Register notice discussed in the Update.
July 30, 2008
FDA Seeks Comments on Newly-Enacted Section 301(ll) of the Food, Drug, and Cosmetic Act Which Prohibits the Interstate Shipment of Certain Foods
The U.S. Food and Drug Administration recently published a notice in the Federal Register (73 FR 43937) requesting data, information, and comments relevant to the agency's implementation of Section 912 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). We are issuing this Constituent Update to alert you to this request and to encourage you to submit relevant data, information, and comments. You may submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may also submit electronic comments to www.regulations.gov. All comments are to be submitted by October 27, 2008.
Section 912 of FDAAA establishes section 301(ll) in the Food, Drug, and Cosmetic Act, which prohibits the interstate shipment of certain foods to which an approved drug or a licensed biological product has been added. Section 301(ll) also prohibits the interstate shipment of foods containing an added drug or a biological product that has been the subject of substantial clinical investigations, the existence of which has been made public. Foods that may be affected by the provisions of section 301(ll) include human food, including infant formula, medical foods, and dietary supplements, and their ingredients; food contact substances, including most food packaging; and animal feed, including pet food and feed ingredients. We are seeking comments about the impact of section 301(ll) on food in all its forms, including food ingredients, categories of food, and finished food products.
We believe that section 301(ll) presents a number of questions of statutory interpretation for our consideration. So that we may better understand the impact of various interpretations of section 301(ll), we are requesting comments on possible approaches to implementation and the impact of those approaches. We have included in the Federal Register notice a series of questions to guide your responses to our request for comments.
If you have questions about this request for comments, you may contact Catherine Copp at Catherine.copp@fda.hhs.gov.
Federal Register Notice; July 29, 2008: Food and Drug Administration Amendments Act of 2007; Prohibition Against Food to Which Drugs or Biological Products Have Been Added; Request for Comments
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 31 Jul 2008 16:02:55 -0500 (CDT)
Subject: Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets (July 31)
Manufacturer for Wegmans Brand Sorbet Issues an Allergen Alert for Undeclared Milk on a Limited Number of Wegmans Brand Sorbets (July 31)
Thu, 31 Jul 2008 15:49:00 -0500
The manufacturer of Wegmans Sorbet is recalling a limited number of 16 oz. Wegmans brand Sorbets because they may contain undeclared milk. People who have an allergy to milk run the risk of a serious or possible life-threatening allergic reaction if they consume the affected products.
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 31 Jul 2008 14:12:42 -0500 (CDT)
Subject: FDA MedWatch- Erythropoiesis Stimulating Agents: Procrit, Epogen, and Aranesp- FDA Clarifies Approved Conditions For Use Of ESAs In Patients With Cancer And Revises Dosing Directions
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Amgen and FDA informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for Erythropoiesis Stimulating Agents (ESAs). The changes clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should be initiated. Additional revisions to prescribing information that ESAs are not intended for use in patients receiving myelosuppressive therapy when the expected outcome is cure and when to initiate and discontinue ESA dosing will be forthcoming. FDA continues to encourage healthcare professionals to discuss with their patients before starting or continuing therapy with ESAs, the benefits of treatment with ESAs and the potential and demonstrated risks of ESAs for thrombovascular events, shortened time to tumor progression or recurrence, and shortened survival time.
Read the entire 2008 MedWatch Safety Summary, including a link to the FDA's Follow Up to an Ongoing Safety Review regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#ESA2
Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 31 Jul 2008 14:20:28 -0500 (CDT)
Subject: FDA MedWatch -Viapro 375mg Capsules- Voluntary Recall Because The Product Was Found To Contain A Potentially Harmful Analog Of Sildenafil
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EG Labs, LLC, notified consumers and healthcare professionals not to buy or use Viapro 375mg Capsules because one lot of the product was found to contain a potentially harmful undeclared ingredient, thio-methisosildenafil, an analog of sildenafil, a FDA approved product used to treat erectile dysfunction in men to enhance sexual performance. The undeclared ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take products containing nitrates. Consumers who have this product should discontinue using it and consult their healthcare professional if they experience any problems that may be related to taking Viapro.
Read the entire 2008 MedWatch Safety summary, including a link to the manufacturer's Press Release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Viapro
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