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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Apr 2008 05:31:02 -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 30, 2008 |
The following new items were added to the CDRH web pages on April 29, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Brief Summary |  |
Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Apr 2008 08:14:41 -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, 30 Apr 2008 09:04:34 -0500 (CDT)
Subject: FDA Embarks on Major Hiring Initiative for its Public Health Mission
FDA Embarks on Major Hiring Initiative for its Public Health Mission
Wed, 30 Apr 2008 08:41:00 -0500
The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation.
Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Apr 2008 17:04:08 -0500 (CDT)
Subject: Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction
Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction
Wed, 30 Apr 2008 15:17:00 -0500
Device manufacturer Physio-Control, Inc., its parent company Medtronic, Inc., and their two top executives have signed a consent decree of permanent injunction related to Automatic External Defibrillators (AEDs) manufactured by Physio-Control, Inc.
Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Apr 2008 13:21:47 -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, 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:
Actavis Totowa LLC recalls all strengths of Digitek (Apr 28)
Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient.
Between January 1 and June 30, 2007, FDA received 85 post-marketing reports in which patients who switched from Wellbutrin XL 300 mg to Teva’s bupropion formulation (Budeprion XL 300 mg) experienced an undesirable effect.
PRODUCT APPROVALS:
FDA approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over. There is currently no prescription drug therapy for IBS-C. With this approval, Amitiza becomes the only FDA-approved medical treatment for IBS-C available in the United States
Coronary Artery Plaque Imaging Device Cleared by FDA (Apr 29)
FDA has cleared for marketing a device that a doctor can use to see inside a blood vessel to assess the fat content of the plaque which builds up on the wall of the coronary arteries.
FDA Approves Relistor for Opioid-Induced Constipation (Apr 24)
FDA approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain.
FDA Approves Cimzia to Treat Crohn's Disease (Apr 22)
A new drug has been approved to help sufferers of Crohn's disease. Cimzia (certolizumab pegol) received approval for adults with moderate to severe Crohn's disease who have not responded to conventional therapies. This product was approved with a Medication Guide.
FDA Approves First Compact Heart Assist Device (Apr 21)
FDA approved a heart assist device with a novel design that is the first to mechanically support the weakened heart of a small-sized adult man or woman with heart failure who is at risk of dying while awaiting a heart transplant.
RECENT ANNOUNCEMENTS:
Biologists, chemists, medical officers, mathematical statisticians and investigators are among the experts in demand as the FDA begins a multi-year hiring initiative.
FDA is summarizing important information relating to medical products that contain potentially contaminated heparin and is seeking assistance from healthcare facilities and providers in identifying and reporting adverse events related to these products.
Bisphenol A (BPA) (Apr 14)
During the week of April 14, 2008, upon the request of the Commissioner of Food and Drugs, FDA formed an agency-wide BPA (Bisphenol A) task force to facilitate cross-agency review of current research and new information on BPA for all FDA regulated products. As a result of this review, the task force will make recommendations to the Commissioner regarding next steps.
UPCOMING MEETINGS:
Blood Products Advisory Committee
DATE AND TIME: May 1-2, 8:30 a.m.
LOCATION: Hilton Hotel, Washington DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852
CONTACT: Donald W. Jehn or Pearline K. Muckelvene, Center for Biologics Evaluation and Research, 301- 827-0314. More Information
Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
DATE AND TIME: May 5-6, 8:00 a.m.
LOCATION: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., Gaithersburg, MD
CONTACT: Teresa Watkins, Center for Drug Evaluation and Research, 301-827-7001. More Information
Anesthetic and Life Support Drugs Advisory Committee
DATE AND TIME: May 7, 8:00 a.m.
LOCATION: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., Gaithersburg, MD
CONTACT: Teresa Watkins, Center for Drug Evaluation and Research, 301-827-7001. More Information
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.
RESOURCES:
MedWatch -- The FDA Safety Information and Adverse Event Reporting Program allows healthcare professionals and consumers to voluntarily report serious problems that they suspect are associated with the drugs and medical devices they prescribe, dispense, or use. These problems include serious adverse reactions and events, product quality problems, and product use errors. Reporting can be done online, by phone, or by submitting the MedWatch 3500 form by mail or fax. Visit the MedWatch How To Report page for more details.
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
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