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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 16 Apr 2008 05:49:33 -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 16, 2008 |
The following new items were added to the CDRH web pages on April 15, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | PMA Final Decisions for March 2008 |  |
Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 16 Apr 2008 08:29:40 -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, 16 Apr 2008 12:06:09 -0500 (CDT)
Subject: Grand Carnival L.L.C Issues Allergy Alert on Undeclared Milk in its "S'morestick Kit" (April 16)
Grand Carnival L.L.C Issues Allergy Alert on Undeclared Milk in its "S'morestick Kit" (April 16)
Thu, 17 Apr 2008 11:44:00 -0500
The recalled "S'morestick Kits" were in limited distribution to Garden Ridge retail stores located in TX, KY, MO, TN, OK, NC, FL, SC, GA, IL, OH, VA, AR, MI, and IN, and bear the "Use By" date of "2/14/09". The "S'morestick Kit" is packaged in a clear plastic tube containing individual clear plastic packages of marshmallows, graham crackers, and chocolate pieces. S'morestick Kits subject to this recall do NOT have a "contains milk" statement following the ingredient statement affixed to the clear plastic tube. There is no health risk for consumers who are not allergic to milk.
Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 16 Apr 2008 12:50:12 -0500 (CDT)
Subject: FDA Update for Health Professionals - April 16, 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:
Salmonella Illnesses in Multiple States may be Linked to Recently Recalled Cereal (Apr 12)
FDA announced that at least 21 people in 13 states have been diagnosed with salmonellosis that was caused by the same strain of Salmonella that was found in the recently recalled unsweetened Puffed Rice and unsweetened Puffed Wheat Cereals produced by Malt-O-Meal.
Communication About an Ongoing Safety Review of CellCept and Myfortic (Apr 10)
FDA is investigating a potential association between the use of CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid), medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease.
Schwarz Pharma recalls Neupro (Apr 9)
Schwarz Pharma informed healthcare professionals and patients of the recall of Neupro, a transdermal delivery system worn on the skin and used to treat early stage Parkinson’s disease, because of the formation of rotigotine crystals in the patches.
Pfizer updates prescribing information for Exubera (Apr 9)
Pfizer informed healthcare professionals and patients of updated safety information in the WARNINGS section of prescribing information for Exubera, a short-acting insulin you breathe in through your mouth using the Exubera inhaler that helps to control high blood sugar in adults with diabetes.
FDA Finds Hazardous Levels of Selenium in Samples of "Total Body Formula" and "Total Body Mega Formula" (Apr 9)
FDA announced that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products.
PRODUCT APPROVALS:
FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus (Apr 3)
FDA announced the approval of Rotarix, the second oral
For a complete description of approvals of FDA-regulated products, please visit http://www.fda.gov/opacom/7approvl.html
RECENT ANNOUNCEMENTS:
Federal Authorities Seize More Than $100,000 of Unapproved Drugs Marketed as "Natural Supplements" (Apr 9)
At the request of
FDA Appoints Dr. Frank M. Torti to Senior Leadership Position (Apr 9)
FDA announced the appointment of Frank M. Torti, M.D., M.P.H. as Principal Deputy Commissioner and first Chief Scientist. As Chief Scientist and a member of the agency's senior leadership team, Dr. Torti will support the launch of the FDA Fellowship Program, which has the potential to attract up to 2,000 professionals of varying disciplines for a two year training program.
UPCOMING MEETINGS:
Ophthalmic Devices Panel of the Medical Devices Advisory Committee
DATE AND TIME: April 24-25, 8:30 a.m.
LOCATION: Gaithersburg Holiday Inn, Ballroom, 2 Montgomery Village Ave.,
CONTACT: Karen F. Warburton, Center for Devices and Radiological Health, 240-276-4238. More Information
Public Hearing on Antimicrobial Resistance
DATE AND TIME: April 28, 8:00 a.m.
LOCATION: University System of
- Written or electronic notices of participation should be submitted by the close of business on Monday, April 21, 2008. Written or electronic comments will be accepted until Monday, May 26, 2008.
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
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee
DATE AND TIME: May 16, 8:00 a.m.
LOCATION: Holiday Inn, Grand Ballroom, Two Montgomery Village Ave.,
CONTACT: Michael Bailey, Center for Devices and Radiological Health, 240-276-4100. More Information
RESOURCES:
A Guide to Drug Safety Terms at FDA
FDA approves a drug for marketing after determining that the drug's benefits of use outweigh the risks for the condition that the drug will treat. But even with a rigorous evaluation process, some safety problems surface only after a drug has been on the market and has been used in a broader population. This guide offers descriptions of some of the drug safety terms commonly used by FDA throughout the life cycle of a drug.
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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