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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 11 Jun 2008 07:48:02 -0500 (CDT)
Subject: CDRH New Update
 | Date: June 11, 2008 |
The following new items were added to the CDRH web pages on June 10, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Anesthesiology and Respiratory Therapy Devices Panel Advisory Meeting, June 12, 2008 - Agenda, Roster, Briefing, Questions |  |
| Consumer Information on: ELA Ovatio CRT-D System - P060027 | |
| Consumer Information on: Talent™ Thoracic Stent Graft System - P070007 | |
Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 11 Jun 2008 08:19:38 -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, 11 Jun 2008 09:00:13 -0500 (CDT)
Subject: Recent Device Approvals: Medtronic Talent™ Thoracic Stent Graft System
You are subscribed to Recent Device Approvals updates for U.S. Food & Drug Administration (FDA). Information about Medtronic's Talent™ Thoracic Stent Graft System has recently been posted to the FDA website, and is now available.
Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 11 Jun 2008 13:59:08 -0500 (CDT)
Subject: FDA Update for Health Professionals - June 11, 2008
U.S. Food and Drug Administration
Office of Special Health Issues
5600 Fishers Lane, HF-12
Rockville, Maryland 20857
Dear Colleague,
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:
ETHEX Corporation announced on June 9, 2008, that it has voluntarily recalled a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an "ETHEX" label between April 16th and April 27th of 2008. No other dosage strength, nor any other lot of the 60 mg strength is affected by this recall.
As part of an ongoing effort, a subcommittee of the FDA's Science Board will hold a public meeting on the safety of bisphenol-A (BPA) in plastics, review an Agency Task Force report on the topic, and deliver its findings to the Board's annual meeting this fall.
Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles.
On June 6, 2008, the U.S. Food and Drug Administration announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients. For additional information please see, Communication about the Ongoing Safety Review of Regranex (becaplermin).
Leiner Health Products Inc. ("Leiner" or "the Company") announced on June 6, 2008, that it is recalling its 32 ounce plastic bottles of Liquimax Complete Nutrition Multivitamin Formula, labeled with UPC Code 7497052290, 7497023607, or 7497023696 because the product may contain undeclared fish (not shellfish), tree nuts (almonds, pecans and/or walnuts), and wheat. People who have allergies to fish, tree nuts and/or wheat run the risk of serious or life-threatening allergic reaction if they consume these products.
The recalled Liquimax Multivitamin was distributed nationwide in retail stores.
Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia) (June 4, 2008)
FDA is investigating the possible association between the use of medicines known as tumor necrosis factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. These individuals were treated with TNF blockers for Juvenile Idiopathic Arthritis (JIA), Crohn’s disease or other diseases. JIA is the new name for what was called Juvenile Rheumatoid Arthritis (JRA).
PRODUCT APPROVALS:
For information on product approvals, please visit Approvals of FDA-Regulated Products
ANNOUNCEMENTS
On June 9, 2008, HHS Secretary Leavitt announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA.
The action supports the fundamental change in strategy currently underway at FDA to adapt to the demands of the rapidly growing and changing global economy. These funds will expedite implementation of the strategy outlined in the Action Plan for Import Safety and the complementary Food Protection Plan, both released in November 2007.
FDA has been informed that King Pharmaceuticals®, Inc. has decided to discontinue the manufacture of several products.
· Intal Nebulizer Solution (cromolyn sodium inhalation solution) (May 30, 2008)
FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now as CFC-propelled inhalers no longer available as of Dec. 31, 2008 (May 30, 2008)
On May 30, 2008, the U.S. Food and Drug Administration issued a public health advisory to alert patients, caregivers and health care professionals to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the United States after Dec. 31, 2008.
FDA's Hiring Initiative
The Food and Drug Administration is recruiting for 1,300 medical and science positions to strengthen the agency's public health mission. The FDA has been granted "direct hire" authority to fill these positions quickly with qualified applicants. For dates and schedules for job fairs, please visit FDA's Nationwide Job Fairs.
UPCOMING MEETINGS:
Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee
DATE AND TIME: June 12, 8:00 a.m.
LOCATION: Hilton Washington DC North/Gaithersburg, Salons A, B, & C, 620 Perry Pkwy., Gaithersburg, MD
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
Cardiovascular and Renal Drugs Advisory Committee
DATE AND TIME: June 25, 8:00 a.m.
LOCATION: Hilton Washington DC/Silver Spring, Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD
CONTACT: Elaine Ferguson, Center for Drug Evaluation and Research, 301-827-7001. More Information
Endocrinologic and Metabolic Drugs Advisory Committee
DATE AND TIME: July 1-2, 8:00 a.m.
LOCATION: Hilton Washington DC/Silver Spring, The Ballroom, 8727 Colesville Rd, Silver Spring, MD
CONTACT: Paul Tran, Center for Drug Evaluation and Research, 301-827- 7001. More Information
Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee and the Psychologic Drugs Advisory Committee
DATE AND TIME: July 10, 8:00 a.m.
LOCATION: Sheraton College Park Hotel, The Ballroom, 4095 Powder Mill Rd., Beltsville, MD
CONTACT: Yvette Waples, Center for Drug Evaluation and Research, 301-827-7001. More Information
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
DATE AND TIME: July 15, 8:00 a.m.
LOCATION: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD
CONTACT: Ronald P. Jean, Center for Devices and Radiological Health (HFZ-410), 240-276-3676., 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
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology
DATE AND TIME: July 22-23, 8:30 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: Diem-Kieu Ngo, Center for Drug Evaluation and Research, 301-827-7001. More Information
Arthritis Advisory Committee
DATE AND TIME: July 29, 8:30 a.m.
LOCATION: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD
CONTACT: Nicole Vesely, Center for Drug Evaluation and Research (HFD-21), 301-827-6793. More Information
RESOURCES:
FDA 101: How to Use the Consumer Complaint System and MedWatch
If you have a complaint about a product regulated by the Food and Drug Administration (FDA), the agency wants to hear about it. FDA offers a number of ways to report a complaint. Two of the main reporting systems available to consumers are the Consumer Complaint Reporting system and MedWatch
Your Guide to Reporting Problems to FDA
Consumers play an important public health role by reporting to the Food and Drug Administration (FDA) any adverse events (unexpected side effects) after using a medical product, or other problems with any products that the agency regulates. Timely reporting allows the agency to take prompt action.
FDA Consumer Health Information page contains articles you may wish to use in your newsletter or link to from your organization's Web site. 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,
Janelle Derbis, PharmD
Janelle.derbis@fda.hhs.gov
312-596-6516 (Chicago)
Brenda L. Evelyn, SBB(ASCP)
Brenda.evelyn@.fda.hhs.gov
301-827-4460
Heidi Marchand, PharmD
Heidi.marchand@fda.hhs.gov
301-827-4460
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