FDA News Digest for May 15, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest     

May 15, 2006

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IN THIS WEEK'S ISSUE

»  News

    -- New Type of Therapy Approved to Help Stop Smoking

    -- FDA Reviewing European Study of Sweetener Aspartame

    -- Latest 'Patient Safety News' Video Available Online

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

New Type of Therapy Approved to Help Stop Smoking

FDA has approved Chantix, an oral drug that can help people quit smoking by acting on sites in the brain affected by nicotine. The drug provides some nicotine effects to help ease withdrawal, and it blocks nicotine effects if smoking is resumed.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01370.html

 

FDA Reviewing European Study of Sweetener Aspartame

FDA is evaluating a study of aspartame consumption in rats conducted by the European Ramazzini Foundation (ERF) in which ERF scientists concluded that the sweetener causes cancer and that current uses should be re-evaluated. FDA plans to complete its review of ERF study data and announce its conclusion as soon as possible. A recent review of the ERF data by the European Food Safety Authority stated that the cancer link is not supported by available data and that there is no need to revise daily intake recommendations.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01369.html 

 

Latest 'Patient Safety News' Video Available Online

FDA has posted the latest edition of "Patient Safety News," a Web-based video news program aimed primarily at health professionals. The program features information on new drugs, biologics, and medical devices, as well as FDA safety notifications and product recalls.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm

 

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

 

Device Recalls:

 

Bausch & Lomb ReNu with MoistureLoc contact lens cleaning solution

    Reason for recall: may increase the risk of infection with Fusarium fungus

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01371.html

Food Recalls: 

 

Nutritech Corp.'s All One Calcium Complex; 8.5-oz. jug

    Reason for recall: undeclared milk

http://www.fda.gov/oc/po/firmrecalls/nutritech05_06.html

 

Exotic Sweets Brand Kaju Katli sweets; 14-oz. size

    Reason for recall: undeclared milk

http://www.fda.gov/oc/po/firmrecalls/rajbhog05_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

May 17 -- Peripheral and Central Nervous System Drugs Advisory Committee

    Under discussion: a proposed treatment for dementia associated with Parkinson's disease

    Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2006/cder12543d051706.html

 

May 17-18 -- Industry Exchange Workshop on FDA Clinical Trial Requirements

    Under discussion: FDA and industry perspectives on proper conduct of clinical trials regulated by FDA

    Location: Baltimore

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-3229.htm

 

May 18 -- Vaccines and Related Biological Products Advisory Committee

    Under discussion: safety and effectiveness of a human papillomavirus vaccine

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-6509.htm

 

May 19 -- Research Review Subcommittee of the Vaccines and Related Biological Products Advisory Committee

    Under discussion: the research program at the Office of Vaccines Research and Review

    Location: Gaithersburg, Md.

http://www.fda.gov/cber/advisory/vrbp/vrbp0506sub.htm

 

May 23 -- Radiological 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/2006/cdrh12526d052306.html

 

May 23-24 -- 9th Annual FDA-0range County Regulatory Affairs Educational Conference

    Under discussion: approvals, compliance and risk management for drugs, devices and biological industries

    Location: Newport Beach, Calif.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-4092.htm

 

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

 

Where can I get information about clinical trials for cancer or other conditions?

 

Some good sources:

 

»  CancerNet (http://cancernet.nci.nih.gov/) provides links to cancer information, information about ongoing clinical trials, as well as National Cancer Institute fact sheets and other publications.

» Clinical Trials.gov (http://www.clinicaltrials.gov/) can help you locate both government and privately sponsored clinical trials for cancer and other serious illnesses.

»  FDA's Clinical Trials page (http://www.fda.gov/oashi/clinicaltrials/default.htm) provides miscellaneous information for consumers and patients about clinical trials.    

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