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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 19 Mar 2008 05:46:09 -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: March 19, 2008 |
The following new items were added to the CDRH web pages on March 18, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | FDA Public Health Notification: Updated Data on Mortality Associated with the Medtronic AneuRx® Stent Graft System |  |
| Medical Devices Dispute Resolution Panel Advisory Meeting, April 19, 2007 - Minutes | |
Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 19 Mar 2008 09:01:36 -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, 19 Mar 2008 09:25:01 -0500 (CDT)
Subject: Mortality Data Associated with the AneuRx® Stent Graft System - Medical Device Safety Update
Healthcare providers should be aware of a new public health notification that re-emphasizes the need for continued surveillance of patients treated with endovascular grafts and to provide updated information on the mortality risks associated with the use of the Medtronic AneuRx® Stent Graft System.
Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 19 Mar 2008 11:05:00 -0500 (CDT)
Subject: Food For Life Baking Co., Inc. Recalls Spelt Bread (March 18)
Food For Life Baking Co., Inc. Recalls Spelt Bread (March 18)
Wed, 19 Mar 2008 10:18:00 -0500
Food For Life Baking Company of Corona, California is voluntarily recalling 2,241 cases of Spelt Bread (UPC# 07347200168) because they contain spelt grain which is known to be a hybrid of wheat. People who have allergies to wheat or those with Celiac Disease may run the risk of a serious or life threatening allergic reaction if they consume spelt products.
Message: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 19 Mar 2008 14:05:16 -0500 (CDT)
Subject: Williams Foods, Inc. Issues Allergy Alert on Undeclared Milk in Bass Pro Shops Uncle Buck's Light 'N Krispy Fish Batter Mixes (March 18)
Williams Foods, Inc. Issues Allergy Alert on Undeclared Milk in Bass Pro Shops Uncle Buck's Light 'N Krispy Fish Batter Mixes (March 18)
Wed, 19 Mar 2008 13:12:00 -0500
The product is sold in Bass Pro Shops Uncle Buck's labeled 22 ounce canisters and 8 ounce flexible pouches. This recall applies to the following lot numbers: 31207A11, 35107A11, 06308A11 (22 ounce canisters) and 3530716 (8 ounce pouches). Only the "Light 'n Krispy" version of the Bass Pro Shop's Uncle Buck's Fish Batter Mixes are affected by this recall.
Message: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 19 Mar 2008 17:04:00 -0500 (CDT)
Subject: FDA Approves New Medical Adhesive to Treat Burn Patients
FDA Approves New Medical Adhesive to Treat Burn Patients
Wed, 19 Mar 2008 16:01:00 -0500
The U.S. Food and Drug Administration today approved a new medical adhesive (a fibrin sealant) called Artiss for use in attaching skin grafts onto burn patients.
Message: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 19 Mar 2008 11:16:03 -0500 (CDT)
Subject: FDA Update for Health Professionals - March 19, 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:
Heparin Update (Mar 19)
FDA held a media briefing to provide an update on FDA’s investigation into severe allergic reactions associated with heparin products made by Baxter Healthcare Corporation. Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, gave brief comments. The presentation was followed by a question and answer session.
· A replay of the briefing will be available starting at 1:00 p.m. EDT on March 19 through March 26, 2008. To hear the replay, callers in the
Early Communication about an Ongoing Safety Review of Tiotropium (Spiriva HandiHaler) (Mar 18)
The manufacturer of Spiriva HandiHaler, Boehringer Ingelheim, recently informed the FDA that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take this medicine.
FDA Public Health Notification: Updated Data on Mortality Associated with the Medtronic AneuRx® Stent Graft System (Mar 17)
FDA issued a Public Health Notification to inform healthcare professionals of an update to earlier FDA safety information on this product. The notification re-emphasizes the need for continued surveillance of patients treated with endovascular grafts, and provides updated information on the mortality risks associated with the use of the AneuRx Stent Graft System to prevent abdominal aortic aneurysm rupture.
Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa) (Mar 12)
Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update information describing the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs.
FDA Issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine
Containing Hydrocodone (Mar 11)
FDA issued an alert on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous reports of adverse events--including death--associated with the misuse and inappropriate use of this potent cough medication.
PRODUCT APPROVALS:
For a complete list of recent product approvals please visit Approvals of FDA-Regulated Products.
RECENT ANNOUNCEMENTS:
FDA releases its second issue of the FDA Drug Safety Newsletter (Mar 18)
The new quarterly issue of FDA's online Drug Safety Newsletter [DSN] has been published today. The current issue includes an article on 'Pharmacogenomics and Drug Safety" and postmarket safety reviews of Exenatide/acute pancreatitis, PDE5 inhibitors/sudden hearing loss, and TNF-alpha antagonists/serious skin reactions.
FDA Launches a New Home Page for its Web site (Mar 18)
The new “front door” is the first visible step toward a complete overhaul of the FDA Web site that began eight months ago as part of a broad agency effort to communicate directly with the public as a means of protecting and promoting health. New features and redesigned pages will be added throughout 2008, and the redesign is scheduled for completion in December.
· Stay tuned—a new health professional portal will be available soon
FDA Takes Next Step in Establishing Overseas Presence (Mar 14)
In an important development, FDA has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China
FDA Names Permanent Director for Center for Drug Evaluation and Research (Mar 10)
Commissioner Dr. Andrew C. von Eschenbach announced the appointment of Janet Woodcock, M.D., as director of the agency's Center for Drug Evaluation and Research.
FDA Warns Companies Importing and Marketing Drugs Over the Internet that Fraudulently Claim to Prevent and Treat STDs (Mar 6)
FDA issued Warning Letters to six U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the Internet to U.S.
UPCOMING MEETINGS:
Pediatric Advisory Committee
DATE AND TIME: March 25, 8:00 a.m.
LOCATION: Hilton , Washington 620 Perry Pkwy. , Gaithersburg , MD
CONTACT: Carlos Pena, Office of Science and Health Coordination, Office of the Commissioner, 301-827-3340. More Information
Anti-Infective Drugs Advisory Committee
DATE AND TIME: April 1-2, 8:00 a.m
LOCATION: Sheraton College Park Hotel, The Ballroom, 4095 Powder Mill Rd., Beltsville, MD
CONTACT: Sohail Mosaddegh, Center for Drug Evaluation and Research, 301-827- 7001. 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, 5630 Fishers Lane , Rockville , MD.
CONTACT: Nicole Vesely, Center for Drug Evaluation and Research, 301-827-6793. More Information
RESOURCES:
DailyMed provides high quality information about marketed drugs. This information includes FDA approved labels (package inserts). This Web site provides health information providers and the public with a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling as found in medication package inserts.
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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