From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 4 Aug 2008 07:53:32 -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: August 4, 2008 |
The following new items were added to the CDRH web pages on August 1, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Guidance for Industry, FDA, and Foreign Governments - FY 2009 Medical Device User Fee Small Business Qualification and Certification |  | |
| Consumer Information on: Invitrogen SPOT-Light® HER2 CISH™ Kit - P050040 |  | |
| Class I Medical Device Recall: Levitronix CentriMag Extracorporeal Blood Pumping System; CentriMag Primary Console (with v200 Application Software On Board) | | |
| Federal Register: Medical Device User Fee Rates for Fiscal Year 2009 | | |
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 4 Aug 2008 08:01:51 -0500 (CDT)
Subject: Medical Device Recalls: Levitronix CentriMag Extracorporeal Blood Pumping System
You are subscribed to Medical Device Recalls for U.S. Food & Drug Administration (FDA). Information about the Levitronix CentriMag Extracorporeal Blood Pumping System Class I Recall has recently been updated, and is now available.
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 4 Aug 2008 08:03:46 -0500 (CDT)
Subject: Recent Device Approvals: SPOT-Light® HER2 CISH™ Kit
You are subscribed to Recent Device Approvals updates for U.S. Food & Drug Administration (FDA). Information about the SPOT-Light® HER2 CISH™ Kit has recently been posted to the FDA website, and is now available.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 4 Aug 2008 08:36:47 -0500 (CDT)
Subject: Levitronix Inc. Blood Pumping System Recall - Medical Device Safety
Levitronix Inc. has recalled the CentriMag Extracorporeal Blood Pumping System due to possible pump stoppage when used with the Valleylab Force FX-C or SSE2L electrosurgical devices.
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 4 Aug 2008 09:03:42 -0500 (CDT)
Subject: Actavis Totowa Announces Voluntary Recall at the Retail Level of All Drug Products Manufactured at its Little Falls, New Jersey Facility (August 1)
Actavis Totowa Announces Voluntary Recall at the Retail Level of All Drug Products Manufactured at its Little Falls, New Jersey Facility (August 1)
Fri, 08 Aug 2008 08:54:00 -0500
Actavis Totowa LLC, a generic drug manufacturer, is announcing a voluntary recall, to the retail level, of all drug products manufactured at its Little Falls, New Jersey facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 4 Aug 2008 11:04:09 -0500 (CDT)
Subject: FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees
FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees
Mon, 04 Aug 2008 10:15:00 -0500
The Food and Drug Administration today announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings.
Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 4 Aug 2008 12:04:36 -0500 (CDT)
Subject: Strengthening the Advisory Committee Process
Strengthening the Advisory Committee Process
Mon, 04 Aug 2008 11:50:00 -0500
FDA is strengthening the process by which it gets expert, independent advice that affects new treatments and other products available to consumers.
Update: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 4 Aug 2008 13:04:08 -0500 (CDT)
Subject: C.F. Sauer Foods Issues Allergy Alert on Undeclared Milk in one lot of Gold Medal Spaghetti Sauce Mix (August 4)
C.F. Sauer Foods Issues Allergy Alert on Undeclared Milk in one lot of Gold Medal Spaghetti Sauce Mix (August 4)
Fri, 08 Aug 2008 12:55:00 -0500
CF Sauer Foods Inc, of Richmond, VA is recalling all packages of Gold Medal Spaghetti Sauce Mix with the code date as follows: 8119R. People who have an allergy or severe sensitivity to milkrun the risk of serious or life threatening allergic reaction if they consume these products.
Update: 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 4 Aug 2008 16:04:00 -0500 (CDT)
Subject: FDA 101: Dietary Supplements
FDA 101: Dietary Supplements
Mon, 04 Aug 2008 15:30:00 -0500
Part of the "FDA 101" series, this article describes how dietary supplements are regulated and offers safety tips for consumers.
Update: 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 4 Aug 2008 16:04:13 -0500 (CDT)
Subject: FDA Law Enforcers Protect Consumers' Health
FDA Law Enforcers Protect Consumers' Health
Mon, 04 Aug 2008 15:30:00 -0500
Inside the FDA's Office of Criminial Investigations
Update: 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 4 Aug 2008 07:41:55 -0500 (CDT)
Subject: FDA MedWatch -The August 2008 FDA Patient Safety News Video is now available...
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FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
Stories in the August 2008 edition include:
Warning Added to Regranex (becaplermin) Label
Use caution when treating diabetic foot and leg ulcers with Regranex in patients who have known malignancies…
Cellcept and Myfortic Linked to Birth Defects and Fetal Loss
Before prescribing these drugs, healthcare professionals should ensure that women are not pregnant and are using two effective forms of birth control…
Possible Association between TNF Blockers and Cancer
Ongoing safety reviews of Remicade, Enbrel, Humira, and Cimzia…
Danger Giving Topical Thrombin Intravascularly
ISMP recommends ways to reduce the risk of errors that can lead to extensive intravascular clotting and death…
Potential Problems with Insulin Pens in Hospitals
Insulin pen design and usage issues can present safety concerns…
Nonoxynol 9 (N9) Contraceptives: No Protection against HIV and Other STDs
Labeling warns that using nonoxynol 9 may increase the risk of contracting HIV/AIDS from an infected partner…
For more
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