Friday, September 5, 2008

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 4 Sep 2008 09:03:19 -0500 (CDT)
Subject: FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures

FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures
Thu, 04 Sep 2008 08:26:00 -0500

The U.S. Food and Drug Administration today announced approval of a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture. This will enable early intervention and lower the risk of serious complications.

Update : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 4 Sep 2008 11:02:51 -0500 (CDT)
Subject: FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections

FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections
Thu, 04 Sep 2008 10:14:00 -0500

The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs' prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died.

Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 4 Sep 2008 11:30:51 -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.

International Conference on Harmonisation (ICH); Draft Guidance: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials andMarketing Authorization for Pharmaceuticals
Posted: 9/4/2008

Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 4 Sep 2008 11:34:52 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Guidances Update

You are subscribed to CBER's Guidances for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

International Conference on Harmonisation (ICH); Draft Guidance: M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials andMarketing Authorization for Pharmaceuticals - 9/4/2008

Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 4 Sep 2008 12:39:48 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) Drug Marketing, Advertising, and Communications Update

FDA announces two new web sites on Medical Product Promotion

 

§         On Tuesday, Sept 2, FDA launched two new Web sites to provide information for consumers and industry about how FDA regulates the promotion of medical products.

 

o       The "Advertising Prescription Drugs and Medical Devices" Web site provides a "one-stop shop" portal to information on FDA regulation of medical product promotion.  Industry and policy users can get directly to relevant laws, regulations, and guidances.  This site can be found at http://www.fda.gov/oc/promotion/

 

o       The direct-to-consumer (DTC) Web site, "Be Smart about Prescription Drug Advertising: A Guide for Consumers"  is designed to educate consumers about how to view such advertising to help inform their discussions with healthcare providers, and consequently to help improve patient understanding and medical care.  This site can be found at:  http://www.fda.gov/cder/ethicad/index.htm

 

§         FDA recognizes the need to provide relevant information that is also engaging and useful.  Toward this goal, the DTC site

o       uses interactive example ads for fictitious drugs to illustrate the different requirements for different types of ads.  This helps users learn in both a visual and written manner. 

o       includes a list of questions consumers should ask themselves when they see a prescription drug ad.  Consumers can print out this list and use it to help discussions with their healthcare providers.

 

§         The DTC site is the first FDA Web site to offer a site-specific survey to give FDA feedback about how well the site addresses users' needs.  Users can answer the survey by clicking on the "Give us feedback" tab.

 

§         The DTC site is also an example of how public-private partnerships can create valuable outcomes for the public.  The site was created in collaboration with EthicAd, an independent, nonprofit organization dedicated to helping consumers, healthcare professionals, and the pharmaceutical and advertising industries in the area of DTC advertising for prescription drugs. (www.ethicad.org)

 

§         A number of other FDA sites will link to the DTC site.  During its initial launch it is being featured on both FDA's and CDER's Home pages.

You are subscribed to Drug Marketing, Advertising, and Communications for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Update : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 4 Sep 2008 14:03:39 -0500 (CDT)
Subject: FDA Approves DNA Test to Measure Hepatitis B Virus Levels

FDA Approves DNA Test to Measure Hepatitis B Virus Levels
Thu, 04 Sep 2008 13:12:00 -0500

The U.S. Food and Drug Administration today approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient's blood. Assessing a patient's viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections.

Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 4 Sep 2008 14:27:14 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Recalls, Withdrawals, Field Corrections & Notifications Update

You are subscribed to CBER's Recalls, Withdrawals, Field Corrections & Notifications for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Medical Device Notification (PSN-08-08) - Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc. - 7/28/2008

Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 4 Sep 2008 19:04:35 -0500 (CDT)
Subject: CDER New

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

CDERnew Logo

September 4, 2008

 

Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 4 Sep 2008 12:09:17 -0500 (CDT)
Subject: MedWatch - Tumor necrosis factor-alpha blockers: delays in diagnosis of fungal and other opportunistic infections

MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Tumor necrosis factor-alpha blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab)
Audience: Rheumatological, gastroenterological and infectious disease healthcare professionals

FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers (TNF blockers). This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients taking TNF blockers who present with signs and symptoms of possible systemic fungal infection, such as fever, malaise, weight loss, sweats, cough, dypsnea, and/or pulmonary infiltrates, or other serious systemic illness with or without concomitant shock, healthcare professionals should ascertain if patients live in or have traveled to areas of endemic mycoses.  For patients at risk of histoplasmosis and other invasive fungal infections, clinicians should consider empiric antifungal treatment until the pathogen(s) are identified. 

Read the complete MedWatch 2008 Safety summary, including links to the Information for Healthcare Professionals page, FDA press release and previous MedWatch alert on these products, at:


http://www.fda.gov/medwatch/safety/2008/safety08.htm#TNF2

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


Posted by at