FDA News
Digest
September 19,
2005
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IN THIS WEEK'S ISSUE
-- Study Examines Defibrillator and Pacemaker Malfunctions
-- FDA Proposes Regulation to Set Standards for PET Drugs
-- Toigo Named Acting Director of FDA
Women's Health Office
-- Recent Speeches
-- Public Meetings
-- Question of the
Week
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Study Examines Defibrillator and Pacemaker Malfunctions
FDA has released a study showing an increase between 1990 and 2002 in the number of malfunctioning implanted cardioverter defibrillators (ICDs) that were removed and replaced. The number of malfunctioning pacemakers, however, decreased during the same period. (ICDs administer a shock to reestablish heart rhythm, while pacemakers electrically stimulate the heart to contract and pump blood.) The study didn't establish a reason for the increase in ICD malfunctions, but it urged improved monitoring of device performance, as well as better ways for doctors to return removed devices to companies for analyses and to report adverse events.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01231.html
FDA Proposes Regulation to Set Standards for PET Drugs
To help ensure that drugs used in positron emission tomography (PET) meet minimum production and testing standards, FDA is proposing a regulation that would set requirements for safety, identity, strength, quality, and purity of the drugs. PET is a medical diagnostic tool in which a radioactive drug is administered to a patient, allowing the uptake of the drug to various organs to be viewed using a special camera. Resulting images help doctors diagnose diseases such as cancer and heart disease.
http://www.fda.gov/bbs/topics/answers/2005/ans01366.html
Toigo Named Acting Director of FDA
Women's Health Office
FDA has appointed Teresa A. Toigo
acting director of the agency's Office of Women's Health. In the position, she
will oversee programs that aim to: ensure FDA functions are gender sensitive and
responsive; correct any gender disparities in medical product testing
and regulation policy; monitor the progress of women's health initiatives within
FDA; and form partnerships with government and non-government groups to
promote women's health objectives. Toigo also directs FDA's Office of Special
Health Issues, which acts as a liaison for patients and their advocates to
participate in the formation of FDA regulatory policy.
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
Various lots of Sara Lee Food & Beverage's products made at the company's Vernon, Calif., bakery, including artisan breads, bagels, English muffins, garlic bread, and pita bread
Reason for recall: products may contain metal and plastic
http://www.fda.gov/oc/po/firmrecalls/saralee09_05.html
Dancing Deer Baking Co.'s Maple Pumpkin Cranberry Streusel Cake; 20-oz. size
Reason for recall: undeclared pecans
http://www.fda.gov/oc/po/firmrecalls/dancingdeer09_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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RECENT SPEECHES
Sept. 16 -- FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., spoke before the Joint Meeting of the FDA and the Heart Rhythm Society.
Subject: heart pacemakers and defibrillators
http://www.fda.gov/oc/speeches/2005/heart0916.html
Sept. 12 -- FDA Commissioner Lester M. Crawford, D.V.M., spoke before the 2005 International Annual Meeting of the American Association of Cereal Chemists.
Subject: FDA's Hurricane Katrina activities and the agency's food safety initiatives
http://www.fda.gov/oc/speeches/2005/LMC0912.html
To view an archive of past
speeches by FDA officials, go to
http://www.fda.gov/speeches/speechli.htm.
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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
Sept. 27 -- General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee
Under discussion: FDA's Critical Path initiative
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12520d092705.html
Sept. 29 -- Blood Products Advisory Committee
Under discussion: a proposed treatment for chronic iron overload due to blood transfusions
Location: Rockville, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cber19516d092905.html
Sept. 29 -- Research Review Subcommittee of the Cellular, Tissue and Gene Therapies Advisory Committee
Under discussion: the research program at FDA's Office of Cellular, Tissue and Gene Therapies
Location: Bethesda, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cber12389d092905.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
Are there any foods
exempt from federal nutrition
labeling requirements?
Yes, under the Nutrition Labeling and Education Act of 1990, these foods are exempt from nutrition labeling:
--
food served for immediate
consumption, such as that served in hospital cafeterias and airplanes, and that
sold by food service vendors (such as mall cookie counters, sidewalk vendors,
and vending machines);
--
ready-to-eat food that is not for
immediate consumption but is prepared primarily on site (such as bakery, deli, and candy store
items);
-- food shipped in bulk, as long as it is
not for sale in that form to consumers;
-- medical foods, such as those used to
address the nutritional needs of patients with certain
diseases;
-- plain coffee and tea, some spices, and
other foods that contain no significant amounts of any nutrients.
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