FDA News Digest
September 12,
2005
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IN THIS WEEK'S ISSUE
-- Food, Drug Safety Information Focus of FDA's Hurricane Katrina Site
-- Generic Version of Child-Friendly Drug Tentatively OK'd for AIDS Relief
-- FDA Offers Patient Information on Recently Approved Medical Devices
-- Recalls/Safety Alerts
-- Congressional Testimony
-- Public Meetings
-- Question of the
Week
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Food, Drug Safety Information Focus of FDA's Hurricane Katrina Site
FDA has created a Web site with links to important health and safety information for consumers affected by Hurricane Katrina. The site is a gateway to material on the safe use of foods, drugs, biological products, and medical devices after the hurricane. Also included is advice on emergency disinfection of water, protecting pets in a disaster, donations, volunteering, and finding missing persons,
http://www.fda.gov/oc/opacom/hottopics/hurricane.html
Generic Version of Child-Friendly Drug Tentatively OK'd for AIDS Relief
FDA has tentatively approved zidovudine oral solution, a generic version of a child-friendly drug treatment for HIV infection and AIDS. The agency's tentative approval means that though existing patents or exclusivity agreements prevent U.S. marketing of the products, the drug meets FDA's standards for quality, safety, and effectiveness. The product will now be available for use outside the United States under the President's Emergency Plan for AIDS Relief.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01230.html
FDA Offers Patient Information on Recently Approved Medical Devices
FDA's Center for Devices and Radiological Health has published online consumer information on three recently approved medical devices. The information, linked on the following list, briefly describes the devices:
-- Xact Carotid Stent System
Intended use: to open blockages in the carotid (neck) artery to help prevent strokes
http://www.fda.gov/cdrh/mda/docs/p040038.html
-- Medtronic Select Secure Lead Model 3830
Intended use: a surgically implanted wire to connect the heart to an implanted pacemaker
http://www.fda.gov/cdrh/mda/docs/p030036.html
-- Matrix VSG System
Intended use: to stop bleeding after cardiac catheterization
http://www.fda.gov/cdrh/mda/docs/p040044.html
To view an archive of past FDA news
releases, go to
http://www.fda.gov/opacom/hpnews.html.
To access the RSS feed of FDA news
releases, go to
http://www.fda.gov/bbs/topics/news/rssPress.xml.
[What is an RSS feed?
See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
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RECALLS/SAFETY ALERTS
Certain lots of Orchid Island fresh-squeezed orange juice
Reason for recall: possible Salmonella contamination
http://www.fda.gov/oc/po/firmrecalls/OrchidIsland9_05.html
For a list of recalls, market
withdrawals, and safety alerts involving FDA-regulated
products from the past 60 days, go
to http://www.fda.gov/opacom/7alerts.html.
To access the RSS feed of FDA
recalls information, go to
http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml.
[What is an RSS feed?
See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
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To view an archive of
past testimony by FDA officials, go
to
http://www.fda.gov/ola/listing.html.
___________________________________________________
Sept. 12-14 -- Parenteral Drug Association/FDA Joint Regulatory Conference; an opportunity for collaboration, education, and networking between FDA and the pharmaceutical and biopharmaceutical industries.
Location: Washington, D.C.
http://www.pda.org/pdafda2005/
Sept. 13 -- FDA "Vision 2006" meeting; this is the first in a series of three public meetings aimed at informing consumers about agency programs and getting feedback. Discussion topics will include drug safety, direct-to-consumer advertising, dietary supplements, FDA's "Critical Path" initiative, and the advisory committee process.
Location: Miami, Fla.
http://www.fda.gov/oc/initiatives/vision2006.html
Sept. 13-14 -- Oncologic Drugs Advisory Committee
Under discussion: pending applications for drugs to treat prostate cancer, leukemia, and lymphoma
Location: Bethesda, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cder12542dd09131405.html
Sept. 26-27 -- National Mammography Quality Assurance Advisory Committee
Under discussion: various issues related to mammography quality standards
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12397dd09262705.html
For a list of FDA meetings,
seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html.
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QUESTION OF THE
WEEK
What is the proper
temperature for your refrigerator?
Refrigerators should stay
at 41° F (5° C) or below. That
temperature range will slow the growth of most bacteria. It won't kill the
bacteria, but it will keep them from multiplying, and the fewer there are, the
less likely you are to get sick from them.
Freezing at zero degrees F (minus 18 °C) or less stops bacterial growth, although it won't kill all bacteria already present. ___________________________________________________
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