FDA News Digest for February 14, 2005

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

Title: Message

FDA News Digest

February 14, 2005

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THIS WEEK'S NEWS

 

--  No Changes Currently Needed in Adderall Labeling or Use, FDA Says

--  Draft Guidance Aims to Boost Development of Radiation Decontamination Drugs

--  Consumers Warned Not to Use Globus Media Home Test Kits

--  FDA Food Security Program Wins Industry E-Government Award

--  Recalls/Market Withdrawals

--  Congressional Testimony

--  Public Meetings

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No Changes Currently Needed in Adderall Labeling or Use, FDA Says

 

In response to Canada's recent suspension of the attention deficit and hyperactivity disorder drugs Adderall and Adderall XR, FDA says no immediate changes in labeling or approved uses for the drugs are warranted in this country. The agency based its decision on its preliminary understanding of Canada's analysis of adverse- event reports and on assessment of its own adverse-event reports related to the drugs.

-- Statement: http://www.fda.gov/bbs/topics/news/2005/NEW01156.html

-- Public Health Advisory:  http://www.fda.gov/cder/drug/infopage/adderall/default.htm

 

Draft Guidance Aims to Boost Development of Radiation Decontamination Drugs

FDA is taking steps to ensure that drugs to eliminate radioactive contamination from the body will be available to protect citizens exposed to radioactive materials from terrorist attacks. The agency is proposing guidance that would advise industry on steps needed to develop and gain approval for these "decorporation agents," which increase the rate of elimination or excretion of radioactive contaminants that may be absorbed, inhaled, or ingested. http://www.fda.gov/bbs/topics/news/2005/NEW01157.html

Consumers Warned Not to Use Globus Media Home Test Kits

 

FDA is warning consumers to avoid home test kits marketed online by Canada-based Globus Media. The kits include unapproved home tests for HIV, syphilis, dengue fever, and pregnancy. FDA has not evaluated the performance of any of the company's products, so consumers cannot be certain that test results are accurate.

http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01340.html

 

FDA Food Security Program Wins Industry E-Government Award

 

The Industry Advisory Council, with represents more than 400 information technology companies, has selected the FDA Industry Systems Web-based registry as one of five federal programs to receive its yearly Excellence.Gov award. The FDA program allows the agency to track food facilities and to receive prior notice of imported food shipments to fulfill requirements created by the Bioterrorism Act of 2002.

http://www.actgov.org/actiac/documents/whatsnew/050209ExcellenceGovTop5.doc

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RECALLS/MARKET WITHDRAWALS

 

The following products are being recalled for the reasons shown. Go to the linked pages for more information. 

 

Methylin CT (methylphenidate HCl) Chewable Tablets; 2.5-, 5-, and 10-mg. doses (may contain too much or too little active ingredient)

http://www.fda.gov/oc/po/firmrecalls/alliant02_05.html

 

Certain egg roll and spring roll products made by Schwan's Food Manufacturing Inc. (may contain small bits of glass)

http://www.fda.gov/oc/po/firmrecalls/minh02_05.html

 

One lot of Similac Advance with Iron infant formula; 12.9-oz. (black plastic particles in some cans)

http://www.fda.gov/oc/po/firmrecalls/ross02_05.html

 

For a listing of recalls, market withdrawals, and safety alerts from the last 60 days involving FDA-regulated products, go to http://www.fda.gov/opacom/7alerts.html.

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CONGRESSIONAL TESTIMONY

 

FDA Center for Biologics Evaluation and Research Director Jesse L. Goodman, M.D.; before the House Committee on Government Reform; subject: "Influenza Vaccine: Current Status, Lessons Learned and Preparing for the Future" (Feb. 10)

http://www.fda.gov/ola/2005/influenza0210.html

 

To view an archive of FDA congressional testimony, go to http://www.fda.gov/ola/listing.html

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PUBLIC MEETINGS

Feb. 14-15 -- Meeting of the FDA Pediatric Advisory Committee; under discussion: an FDA report on adverse event reporting for six drugs that have been granted pediatric marketing exclusivity (Rockville, Md.)                                                                                        http://www.fda.gov/oc/advisory/accalendar/2005/fda12604d02141505.htm

Feb 16-17 --  Meeting of the Vaccines and Related Biological Products Advisory Committee; under discussion: the selection of strains to be used in the 2005-2006 flu vaccine (Bethesda, Md.)                                                                                                             http://www.fda.gov/oc/advisory/accalendar/2005/cber12391dd02161705.html

Feb. 16-18 -- Joint meeting of the FDA Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; under discussion: benefit-risk considerations for COX-2 nonsteroidal anti-inflammatory drugs (Gaithersburg, Md.)              http://www.fda.gov/oc/advisory/accalendar/2005/cder12532ddd0216171805.html

 

April 27-28 -- 11th Annual FDA Science Forum; includes a free public session on personalizing your healthcare, and scientific sessions on nanotechnology, animal models, cancer diagnosis and treatment, risk management, and other topics (Washington, D.C.)                                                 http://www.cfsan.fda.gov/~frf/forum05/sxsf05pr.htm

 

For a list of upcoming FDA meetings, seminars, and other public events, go to

http://www.fda.gov/opacom/hpmeetings.html.

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HOW'S YOUR KNOWLEDGE of health-related topics such as antidepressants for children, dental braces, and heart transplants? Find out by taking the FDA Consumer quiz at http://www.fda.gov/fdac/quiz/onlinequiz21_js.html.

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