Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 06:33:11 -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 : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 07:53:50 -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 18, 2008 |
The following new items were added to the CDRH web pages on September 17, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Medical Devices; Medical Device Reporting; Baseline Reports; Confirmation of Effective Date |  |  |
Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 08:37:29 -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.
Vacancy Announcement - Consumer Safety Officer (CSO)/Lead /Supv CSO
Posted: 9/18/2008
Vacancy Announcement - Consumer Safety Officer (CSO)/Lead /Supv CSO
Posted: 9/18/2008
Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 10:09:15 -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.
PDA/FDA Joint Meeting - Slide Presentations
Posted: 9/18/2008
Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 11:06:19 -0500 (CDT)
Subject: Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10%
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Drug Shortages: Current Drug Shortages; AMMONUL (sodium phenylacetate and sodium benzoate) Injection 10%/10%
Thu, 18 Sep 2008 09:10:00 -0500
See information in Related Information section.
Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 13:34:30 -0500 (CDT)
Subject: Drug Safety Newsletter Update
You are subscribed to Drug Safety Newsletter for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 15:08:26 -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.
"Mammography Equipment Evaluation (MEE) Scope for Newly Installed FFDM Systems"
Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 15:10:07 -0500 (CDT)
Subject: FDA MedWatch- FDA Drug Safety Newsletter- Summer 2008 Edition Available For Healthcare Professionals And The Medical Community
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The Drug Safety Newsletter is a FDA publication for healthcare professionals and the medical community. The newsletter provides information on the findings of selected postmarketing drug safety reviews from FDA's Center for Drug Evaluation and Research. The newsletter also provides information on important emerging drug safety issues and recently approved new molecular entities. FDA hopes the newsletter will raise awareness of reported adverse events, and stimulate additional adverse event reporting by healthcare professionals.
Postmarketing Reviews:
Mefloquine Hydrochloride: Reports of Pneumonitis
Lenalidomide: Serious Skin Reactions
Amiodarone-Simvastatin Interaction: Reports of rhabdomyolysis
Icodextrin Portable Blood Glucose Monitor Test Strip Interaction: Reports of iatrogenic, sometimes fatal, hypoglycemia
Publication of this newsletter fulfills a commitment FDA made in its January 2007 response to the Institute of Medicine's (IOM) 2006 Report on The Future of Drug Safety - Promoting and Protecting the Health of the Public.
Read the entire MedWatch 2008 Safety Summary, including a link to the FDA Drug Safety Newsletter at:
http://www.fda.gov/cder/dsn/2008_summer/toc.htm
Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 15:48:34 -0500 (CDT)
Subject: New Issue of Maturity Health Matters Now Available!
The Fall 2008 edition of Maturity Health Matters is now available online.
Recent major hurricanes make the first article, "Preparing for Natural Disasters" very important to our readers. The next two articles contain information on "Injectable Cosmetic Wrinkle Fillers" and "Vaccines – Staying Healthy."
We have published information on FDA's MedWatch in two previous issues, but because we believe that consumers and patients play such an important role in public health by reporting problems they have with products that FDA regulates, we have provided more information on MedWatch.
The new issue is now available at http://www.fda.gov/cdrh/maturityhealthmatters.
Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 09:02:24 -0500 (CDT)
Subject: FDA Issues Draft Guidance on Regulating Genetically Engineered Animals
FDA Issues Draft Guidance on Regulating Genetically Engineered Animals
Thu, 18 Sep 2008 09:00:00 -0500
The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals.
Update : 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 11:06:15 -0500 (CDT)
Subject: Enforcement Report for September 17, 2008
Enforcement Report for September 17, 2008
Thu, 18 Sep 2008 08:28:00 -0500
Weekly report by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
Update : 12
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 11:06:17 -0500 (CDT)
Subject: Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection)
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Drug Shortages: Drugs to be Discontinued; Mitozytrex (Mitomycin for Injection)
Thu, 18 Sep 2008 09:10:00 -0500
See Web site for additional information.
Update : 13
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 11:06:18 -0500 (CDT)
Subject: FDA Proposes Label Requirements for Refused Imported Foods
FDA Proposes Label Requirements for Refused Imported Foods
Thu, 18 Sep 2008 10:17:00 -0500
The U.S. Food and Drug Administration today issued a proposed rule designed to reduce a practice known as "port shopping" which puts the safety of imported food at risk.
Update : 14
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 11:06:22 -0500 (CDT)
Subject: Draft Guidance on Genetically Engineered Animals
Draft Guidance on Genetically Engineered Animals
Thu, 18 Sep 2008 10:00:00 -0500
The technology of genetic engineering offers many benefits for health, agriculture, and the environment. FDA tells how it is regulating genetically engineered animals.
Update : 15
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 13:13:33 -0500 (CDT)
Subject: FDA MedWatch - Phosphocol P 32- Risk Of Leukemia Associated With Off-Label Intra-articular Use In Children
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Covidien and Mallinckrodt Inc. informed healthcare professionals of important new safety information in prescribing Phosphocol P 32. Phosphocol P 32 is approved for the intracavitary instillation for the treatment of peritoneal or pleural effusions caused by metastatic disease. Phosphocol P 32 may increase the risk for leukemia in certain situations. Two children (ages 9 and 14) with hemophilia developed acute lymphocytic leukemia approximately 10 months after intra-articular injections of Phosphocol P 32 (0.6 and 1.5 mCi total dose). This drug is not indicated in the intra-articular treatment of hemarthroses. Additionally, post marketing experience identified radiation injury (necrosis and fibrosis) to the small bowel, cecum, and bladder following administration of P 32 into the peritoneal cavity. Healthcare professionals should refer to the product's revised prescribing information for updated information regarding the appropriate use of Phosphocol P 32.
Read the entire 2008 MedWatch Safety Summaries, including a link to the manufacturer's Dear Healthcare Provider Letter and the revised prescribing information for Phosphocol P 32.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Phosphocol
Update : 16
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 18 Sep 2008 18:02:45 -0500 (CDT)
Subject: K-Fat Inc. Issues Alert On Undeclared Sulfites In "Mut Gung Sweetened Ginger" (September 18)
K-Fat Inc. Issues Alert On Undeclared Sulfites In "Mut Gung Sweetened Ginger" (September 18)
Thu, 18 Sep 2008 17:09:00 -0500
K-FAT INC. of 13 Meadow St., Brooklyn, NY 11206, is recalling its 150g packages of MUT GUNG SWEETENED GINGER because they contain undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious life-threatening allergic reactions if they consume this product.
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