FDA News Digest for September 2005

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FDA News Digest

 

 

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

-- Recalls/Safety Alerts

-- 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/bbs/topics/news/2005/toigoOWH.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

 

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.

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.

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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PUBLIC MEETINGS

 

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.

 

 

 

 

 

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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