Update : 1
Subject: CDRH New Update
    |
| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
 | ||
 | 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). | | |
Update : 2
Subject: FDA Patient Safety News - April 2008 edition
Here are the headlines for the April 2008 edition of FDA Patient Safety News. Free feel to check out all the stories in this edition as well as stories from previous programs by going to www.fda.gov/psn
- Decellularized Allograft Heart Valve Approved
Recalls and Safety Alerts
- Fentanyl Patches Recalled
- New Safety Warnings about Chantix
- Early Communication on Adverse Events from BoTox and Myobloc
- FDA Takes Action on Injectable Colchicine
- New Data on Thromboembolic Events with Ortho Evra Contraceptive Patch
Preventing Medical Errors
- Remembering to Re-Activate a Patients’s Defibrillator
- Mixups between Insulin U-100 and U-500
Patients Are Asking
- Caution Giving Children Cough and Cold Medicines
Enjoy!
Update : 3
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 : 4
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.
Update : 5
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.
Update : 6
Subject: Enforcement Report for April 2, 2008
Enforcement Report for April 2, 2008
Wed, 2 Apr 2008 14:07:00 -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 : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 2 Apr 2008 15:07:15 -0500 (CDT)
Subject: Drug Shortage: Heparin sodium injection multidose and single dose vials from Baxter and heparin sodium large volume infusion solutions from B. Braun
| ||||||||||||
Drug Shortage: Heparin sodium injection multidose and single dose vials from Baxter and heparin sodium large volume infusion solutions from B. Braun
Mon, 24 Mar 2008 16:00:00 -0500
Information for this shortage has been updated on the Drug Shortage site
Update : 8
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.
Update : 9
Subject: Resolved Drug Shortage: BiCNU (carmustine) Injection
| ||||||||||||
Resolved Drug Shortage: BiCNU (carmustine) Injection
Wed, 2 Apr 2008 15:00:00 -0500
No further supply issues are anticipated. See letter from Bristol-Myers Squibb [more].
Update : 10
Subject: CFSAN Constituent Update April 2, 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 *
April 2, 2008
Food Protection Plan and
Third Party Certification Programs for Foods and Feeds
On Tuesday, April 1, 2008, the U.S. Food and Drug Administration held a teleconference to announce the establishment of two public Dockets. The FDA is requesting information and comments on its 2007 Food Protection Plan that presents a robust strategy to protect the nation's food supply from both unintentional contamination and deliberate attack. The FDA is also requesting stakeholder comments on the use of Third-Party Certification Programs for Foods and Feeds.
Commenting on FDA's Food Protection Plan
FDA encourages interested persons to submit written comments on the Food Protection Plan to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The Federal Register Notice can be viewed and electronic comments can be submitted to http://www.regulations.gov. All comments should be identified with docket number FDA-2008-N-00188.
Third-Party Certification Programs for Foods and Feeds
FDA also encourages interested persons to submit written comments on Third-Party Certification Programs for Foods and Feeds to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The Federal Register Notice can be viewed and electronic comments can be submitted to http://www.regulations.gov. All comments should be identified with the docket number FDA-2008-N-0183.
Teleconference Replay
A replay of the teleconference is available now and ends Tuesday, April 8, 2008 (CT). You can access the replay by calling 1-866-505-6449.
Resource material on the Food Protection Plan is available on the FDA Web site.
Update : 11
Subject: CDER New 4/2/2008
| ||||||||||||
April 2, 2008
- CDER Data Standards Manual: SPL Flavor
- Resolved Drug Shortage: BiCNU
- Drugs@FDA Downloadable Data Files (updated)
- GlaxoSmithKline informs healthcare professionals of changes to the prescribing information for Relenza regarding information from postmarketing reports. MedWatch Safety Information
- Meeting: A Joint FDA/URI College of Pharmacy Conference – FDA and Generic Drugs: An Interactive Forum, June 30 and July 1, 2008 / Hyatt Regency Bethesda Hotel ~ North Bethesda, MD. Meeting Information
[External Site] - New and Generic Drug Approvals
- Diflucan (fluconazole) Tablets, Pfizer Inc., Labeling Revision
- Diflucan in Dextrose 5% in Plastic Container (fluconazole) Injection, Pfizer Inc., Labeling Revision
- Diflucan in Sodium Chloride 0.9% (fluconazole) Injection, Pfizer Inc., Labeling Revision
- Diflucan in Sodium Chloride 0.9% in Plastic Container (fluconazole) Injection, Pfizer Inc., Labeling Revision
- Diflucan (fluconazole) for Oral Suspension, Pfizer Inc., Labeling Revision
- Inderal (propranolol hydrochloride) Injection, Baxter Healthcare, Labeling Revision
- Lotronex (alosetron hydrochloride) Tablets, Prometheus Labs, New Dosage Regimen
- Phentermine Hydrochloride Tablets, KVK-Tech Inc., Approval
- Novartis will no longer make Zelnorm available under a treatment IND protocol.
Update : 12
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
  |
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
Update : 13
Subject: FDA MedWatch - Heparin Sodium USP - Voluntary Nationwide Recall Because Two Lots Had Heparin-like Contaminant
| |
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
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
