FDA News Digest for August 28, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest     

August 28, 2006

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IN THIS WEEK'S ISSUE

»  News

    -- 'Morning After' Pill Given OTC Status for Women 18 and Older

    -- FDA Proposes Rule to Automate Drug Registration and Listing

    -- Appeals Court Upholds Rule Banning Supplements with Ephedra

    -- Alaris Infusion Pumps Seized Due to Potentially Hazardous Defect

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

'Morning After' Pill Given OTC Status for Women 18 and Older

FDA has granted over-the-counter status to the Plan B contraceptive for women 18 and older. Sometimes called emergency contraception or the "morning-after" pill, Plan B can prevent pregnancy if taken within 72 hours of unprotected sex. Previously available by prescription only, Plan B will still require a prescription for women aged 17 and under.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01436.html

-- More information: http://www.fda.gov/cder/drug/infopage/planB/default.htm

 

FDA Proposes Rule to Automate Drug Registration and Listing

FDA has proposed a rule that aims to make managing drug information more efficient by automating the process by which drug companies register themselves and list their products. The goal is to make the complete inventory of drug products marketed in the United States readily available electronically for use by government agencies, healthcare providers, and healthcare payers. Currently, some of this listing is still kept in paper form.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01435.html

 

Appeals Court Upholds Rule Banning Supplements with Ephedra

A Denver federal appeals court has upheld a 2004 FDA rule declaring that dietary supplements containing ephedrine alkaloids (ephedra, or Ma huang) cannot be marketed in the United States. In a statement, FDA calls the Denver decision "consistent" with 1994 dietary supplement legislation and says the decision "supports the agency's findings" regarding the potential risks of ephedra-containing supplements.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01434.html

 

Alaris Infusion Pumps Seized Due to Potentially Hazardous Defect

Federal marshals have seized Alaris Signature Edition Gold infusion pumps worth an estimated $1.8 million because the pumps have a design defect that could cause patients to receive a potentially dangerous over-infusion of medication. Infusion pumps are electronic devices that give patients controlled delivery of intravenous medicines and solutions.  

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01437.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

Food Recalls: 

 

Meadow Gold Hook'd on Chocolate ice cream, 56-oz. size

    Reason for recall: undeclared egg

http://www.fda.gov/oc/po/firmrecalls/meadowgold08_06.html

 

Certain lots of Good Karma Organic Rice Cream Mudd Pie, Organic Rice Cream Mint Chocolate Chip, and Organic Rice Cream Chocolate Peanut Butter Fudge

    Reason for recall: undeclared milk

http://www.fda.gov/oc/po/firmrecalls/goodkarma08_06.html

 

Certain lots of Gerber Fashion Tint Bottles with Silicone Nipples, 3-pack, 9-oz. size

    Reason for recall: bottles contain latex nipples, which could cause allergic reactions in certain people

http://www.fda.gov/oc/po/firmrecalls/gerber08_06.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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UPCOMING PUBLIC MEETINGS

 

Aug. 29 -- Reproductive Health Drugs Advisory Committee

    Under discussion: pending review of a drug to prevent preterm delivery in women with history of preterm delivery

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-11538.htm

 

Aug. 29 -- Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee

    Under discussion: application for a device that would complement clinical breast examination in asymptomatic women, ages 30-39 

    Location: Gaithersburg, Md.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/details.cfm?mtg=664

 

Sept. 6-7 -- Joint meeting of Dental Products Panel of the Medical Devices Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee

    Under discussion: dental amalgam devices

    Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2006/cdrh12518dd09060706.html

 

Sept. 26 -- Risk Communication on Medical Devices: Sharing Information

    Under discussion: how the government and device industry communicate expected and unexpected risks to doctors, patients and the public

    Location: North Bethesda, Md.

http://www.fda.gov/cdrh/meetings/092606-riskcommunication.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

 

Does "freezer burn" make food unsafe?

Freezer burn is a food quality issue, not a food safety issue. It appears as grayish-brown leathery spots on frozen food. It occurs when air reaches the food's surface and dries out the product. This can happen when food is not securely wrapped in air-tight packaging. Color changes result from chemical changes in the food's pigment. Although undesirable, freezer burn does not make the food unsafe. It merely causes dry spots in foods. You can cut away these areas either before or after cooking the food. When freezing food in plastic bags, you can help prevent freezer burn by pushing all the air out before sealing.   

 

For more on food safety, see http://www.foodsafety.gov/.                        

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