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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 2 Apr 2008 05:45:14 -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: April 2, 2008 |
The following new items were added to the CDRH web pages on April 1, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | FDA Seeks Civil Penalties from Calif. Device Maker |  | |
| Summary Information for: FreeStyle Navigator® Continuous Glucose Monitoring System - P050020 |  | |
| Federal Register: The Essentials of Food and Drug Administration Medical Device Regulations: A Primer for Manufacturers and Suppliers; Public Seminar (Notice of public seminar). | | |
Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 2 Apr 2008 09:34:49 -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.
Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 2 Apr 2008 10:11:40 -0500 (CDT)
Subject: Covidien Initiates Voluntary Recall of Pre-Filled Syringes Containing Heparin (March 28)
Covidien Initiates Voluntary Recall of Pre-Filled Syringes Containing Heparin (March 28)
Wed, 2 Apr 2008 09:32:00 -0500
This product recall was initiated due to a notification received from the supplier, SPL, disclosing that two lots of Heparin Sodium USP Active Pharmaceutical Ingredient acquired by Covidien had a heparin-like contaminant. To date, Covidien has not received any adverse event reports related to this issue. Although a very small product line for Covidien, the Company is committed to following the direction of the Food and Drug Administration (FDA) regarding this matter.
Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 2 Apr 2008 14:07:53 -0500 (CDT)
Subject: Mrs Baird's Issues Voluntary Recall of 4" Buns Due to Undeclared Milk (April 1)
Mrs Baird's Issues Voluntary Recall of 4" Buns Due to Undeclared Milk (April 1)
Wed, 2 Apr 2008 13:42:00 -0500
The buns were sold at Costco stores in North Texas in a two count package containing 24 buns and to restaurant and institutional customers in Texas and Oklahoma in 12 count packages.
Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 2 Apr 2008 15:07:20 -0500 (CDT)
Subject: Fresh Express Foods Corporation, Inc. Recalls Cube Cut Cantaloupe Due to Possible Health Risk (March 28)
Fresh Express Foods Corporation, Inc. Recalls Cube Cut Cantaloupe Due to Possible Health Risk (March 28)
Wed, 2 Apr 2008 14:19:00 -0500
Fresh Express Foods Corporation, Inc. of Medford Oregon is voluntarily recalling cut cubed processed cantaloupe. This product was received from C.H. Robinson, supplied by Agropecuaria Montelibano, a grower in Honduras. This product has the potential to be contaminated with Salmonella and with the knowledge of the Food and Drug Administration we have recalled all of the product.
Message: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 2 Apr 2008 12:28:21 -0500 (CDT)
Subject: FDA Update for Health Professionals - April 2, 2008
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent safety information, announcements, product approvals, and upcoming meetings. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
PRODUCT SAFETY INFORMATION:
FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs and Biologics (Mar 27)
FDA has identified 25 drugs and biologic products that will be required to submit safety plans called Risk Evaluation and Mitigation Strategy (REMS). The Federal Register notice, which includes a list of the 25 drugs and biologic products that will be required to submit REMS, is available at www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.htm.
The April Edition of FDA Patient Safety News (PSN) is Now Available
FDA Patient Safety News 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.
Stories in the April 2008 edition include:
- Fentanyl (Duragesic) Patches Recalled
- New Safety Warnings about Chantix
- Early Communication on Adverse Events from Botox and Myobloc
- New Data on Thromboembolic Events with Ortho Evra Contraceptive Patch
- Mixups between Insulin U-100 and U-500
- Caution Giving Children Cough and Cold Medicines
PRODUCT APPROVALS:
For a complete description of approvals of FDA-regulated products, please visit http://www.fda.gov/opacom/7approvl.html
RECENT ANNOUNCEMENTS:
Opportunity for Comment: Food Protection Plan (Apr 1)
FDA held a teleconference to announce the establishment of two public dockets. In one Federal Register notice, FDA requests information and comments on its 2007 Food Protection Plan that presents a strategy to protect the nation’s food supply from both unintentional contamination and deliberate attack. In another, FDA invites comments on Third-Party Certification Programs for Foods and Feeds.
Food Protection Plan: Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration,
Third-Party Certification Programs for Foods and Feeds: Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration,
· A replay of the teleconference is available until Tuesday, April 8, 2008 (CT). You can access the replay by calling 1-866-505-6449.
FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries (Mar 26)
FDA announced it has issued draft guidelines to aid the development, testing and manufacture of coronary drug-eluting stents, devices used to treat blocked heart arteries.
FDA Warns Consumers about "Total Body Formula" and "Total Body Mega Formula" (Mar 27)
FDA is advising consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.
FDA Warns Consumers Not to Use “Blue Steel” and “Hero” Products (Mar 25)
FDA is advising consumers not to purchase or use "Blue Steel" or "Hero" products marketed as dietary supplements throughout the
UPCOMING MEETINGS:
QT and Arrhythmia Issues in Drug Development
DATE AND TIME: April 6-8, 8:00 a.m.
LOCATION: Hyatt Regency
CONTACT: Norman Stockbridge, Center for Drug Evaluation and Research, (301) 796-2240. More Information
Cellular, Tissue, and Gene Therapies Advisory Committee
DATE AND TIME: April 10-11, 9:00 a.m. (8:00 on the 11th)
LOCATION:
CONTACT: Gail Dapolito or Danielle Cubbage, Center for Biologics Evaluation and Research, 301-827-0314. More Information
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
DATE AND TIME: April 16, 8:30 a.m.
LOCATION: Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, rm. 1066,
CONTACT: Nicole Vesely, Center for Drug Evaluation and Research, 301-827-6793. More Information
RESOURCES:
ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the
If you have any questions, you may send an email to webmail@oc.fda.gov or contact us at the numbers listed below. If you do not wish to receive this information updates, you may unsubscribe at this link: FDA Consumer Health Information .
Sincerely,
Brenda L. Evelyn, SBB(ASCP) Janelle Derbis, PharmD
Office of Special Health Issues Office of Special Health Issues
(301) 827-4460 (312) 596-6516
(301) 443-4555 (fax) (312) 886-1682 (fax)
Brenda.evelyn@.fda.hhs.gov Janelle.derbis@fda.hhs.gov
Message: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 2 Apr 2008 12:34:10 -0500 (CDT)
Subject: FDA MedWatch- Relenza (zanamivir) Changes To The WARNINGS AND PRECAUTIONS Sections Of Prescribing Information For Relenza About Postmarketing Reports Of Neurologic And Behavioral Symptoms
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GlaxoSmithKline informed healthcare professionals of changes to the WARNINGS AND PRECAUTIONS sections of prescribing information for Relenza regarding information from postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury in patients with influenza who are receiving neuraminidase inhibitors, including Relenza. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of Relenza to these events has not been established. Influenza can be associated with a variety of neurologic and behavioral symptoms which can include seizures, hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease.
Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.
Read the entire 2008 MedWatch Safety Summary including a link to the manufacturer's Dear Healthcare Professional Letter regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Relenza
Message: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 2 Apr 2008 13:27:21 -0500 (CDT)
Subject: FDA MedWatch - Heparin Sodium USP - Voluntary Nationwide Recall Because Two Lots Had Heparin-like Contaminant
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Covidien notified healthcare professionals of a voluntary recall of certain lots of Heparin Sodium USP because two lots of the product acquired by Covidien had a heparin-like contaminant. To date, Covidien has not received any adverse event reports related to this issue. See the manufacturer's press release for the list of specific lots of the product affected by the recall. Use of the recalled product should be discontinued immediately. Patients should contact their physician if they experience any problems associated with the use of the product.
Read the complete MedWatch 2008 safety summary, including a link to the firm press release, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#heparinsodium
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