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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 14 May 2008 06:23:37 -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: May 14, 2008 |
The following new items were added to the CDRH web pages on May 13, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Radiological Devices Panel Advisory Meeting, March 4-5, 2008 - Transcripts |  |
Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 14 May 2008 09:12:13 -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, 14 May 2008 17:05:19 -0500 (CDT)
Subject: Manufacturer Removes Remaining Stocks of Trasylol
Manufacturer Removes Remaining Stocks of Trasylol
Wed, 14 May 2008 16:53:00 -0500
Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician’s stock. The FDA will work with Bayer to ensure a smooth and complete process.
Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 14 May 2008 17:05:23 -0500 (CDT)
Subject: Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (May 7)
Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (May 7)
Wed, 14 May 2008 16:30:00 -0500
Medtronic, Inc. announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs.
Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 14 May 2008 12:46:31 -0500 (CDT)
Subject: FDA Update for Health Professionals - April 30, 2008
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent safety information, 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:
Ongoing Safety Review of Cefepime (May 14)
On November 14, 2007, FDA announced that it was reviewing safety data that raised concerns about a potential increased mortality in patients treated with cefepime and that FDA had requested additional data from the manufacturer, Bristol-Meyers Squibb (BMS). FDA is continuing to review safety data for the drug cefepime. There are a large number of studies to be reviewed and some, but not all, of the requested study data have been received by the FDA.
Heparin Update (May 12)
FDA requests that health professionals and facilities review and examine all drug/device storage areas to ensure that all recalled heparin products have been removed and are no longer available for patient use.
Revisions to Prescribing information for Enbrel (May 2)
Amgen and Wyeth Pharmaceuticals informed healthcare professionals of revisions to prescribing information for Enbrel. The revisions include a BOXED WARNING about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel.
The May 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 May 2008 edition include:
- FDA Licenses New Hemophilia Treatment
- Unsafe Use of Extended-Release Tussionex Suspension
- Liver Injury with Tysabri
- Updated Labeling Changes for Tamiflu and Relenza
- New Instructions for Using Talecris IG Syringes
- Hepatotoxicity with Prezista
- Information on Mortality Rates with the AneuRx® Stent Graft System
- Mistakenly Swallowing Inhaler Capsules
PRODUCT APPROVALS:
FDA Approves First Generic Ropinirole (May 9)
FDA has approved the first generic versions of Requip (ropinirole hydrochloride) tablets for the treatment of moderate to severe Restless Legs Syndrome.
FDA Approves New Formulation of Coagulation Therapy (May 9)
FDA approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to be stored at room temperature (up to 77 degrees Fahrenheit) for up to two years.
UPCOMING MEETINGS:
Risk Communication Advisory Committee
DATE AND TIME: May 15-16, 8:00 a.m.
LOCATION: Hilton, 1750 Rockville Pike,
CONTACT: Lee L Zwanziger, Office of Planning, 301-827-2895.
Meeting to discuss direct-to-consumer advertising, including how it relates communicating to subsets of the general population such as the elderly, children, and racial and ethnic minority communities.
FDA/DIA Co-Sponsored Conference on the Orphan Drug Act (ODA) at 25 Years: Retrospective and Future Views
DATE AND TIME: May 19, 8:00 a.m.
LOCATION: Capitol Hilton,
CONTACT: Jessica Kusma, DIA, 215-442-6182; email Jessica.Kusma@diahome.org. More Information
Dermatologic and Ophthalmic Drugs Advisory Committee
DATE AND TIME: May 29, 8:00 a.m.
LOCATION: Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, Rm. 1066, 5630 Fishers Lane, Rockville, MD
CONTACT: Yvette Waples, Center for Drug Evaluation and Research, 301-827-7001. More Information
Science Board to the Food and Drug Administration
DATE AND TIME: May 30, 8:00 a.m.
LOCATION:
CONTACT: Carlos Pena, Office of the Commissioner, 301-827-6687. More Information
Oncologic Drugs Advisory Committee
DATE AND TIME: May 30, 8:00 a.m.
LOCATION: Hyatt Regency
CONTACT: Nicole Vesely, Center for Drug Evaluation and Research, 301-827-6793. More Information
Pediatric Ethics Subcommittee of the Pediatric Advisory Committee
DATE AND TIME: June 9-10, 8:30 a.m.
LOCATION: Holiday Inn /Gaithersburg, The Ballroom, Two Montgomery Village Ave., Gaithersburg, MD
CONTACT: Carlos Pena, Office of the Commissioner, 301-827-3340. On June 9, 2008. More Information
Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee
DATE AND TIME: June 12, 8:00 a.m.
LOCATION: Hilton
CONTACT: Neel J. Patel, Center for Devices and Radiological Health, 240-276-3700. More Information
Dermatologic and Ophthalmic Drugs Advisory Committee
DATE AND TIME: June 17-18, 8:00 a.m.
LOCATION: Food and Drug Administration, Center for Drug Evaluation and Research, Advisory Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD
CONTACT: Yvette Waples or John Lauttman, Center for Drug Evaluation and Research, 301-827-7001. More Information
Anti-Infective Drugs Advisory Committee
DATE AND TIME: July 16, 8:00 a.m.
LOCATION: Food and Drug Administration, Center for Drug Evaluation and Research Advisory Committee Conference Room, Rm. 1066, 5630 Fishers Lane, Rockville, MD
CONTACT: Sohail Mosaddegh, Center for Drug Evaluation and Research, 301-827-7001. More Information
RESOURCES:
FDA Consumer Health Information page contains articles you may wish to use in your newsletter or link to from your organization's Web site. This month's feature article is Find the Latest Drug Product and Safety Information. For this article and additional timely content, visit the Consumer Health Information page.
If you have any questions, you may send an email to webmail@oc.fda.gov or contact us at the numbers listed below.
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: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 14 May 2008 20:07:05 -0500 (CDT)
Subject: MedWatch - Trasylol [aprotinin injection] to be removed from all hospital pharmacies, available only under limited use agreement access
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Audience: Cardiovascular healthcare professionals, pharmacists, hospital surgical service managers
Read the complete MedWatch safety summary, including links to the updated drug information page and the FDA news statement, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Trasylol
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