FDA News Digest for November 19, 2007

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Mon, 19 Nov 2007 16:24:27 -0600 (CST)

Title: FDA News Digest for November 19, 2007

    FDA News Digest

    November 19, 2007

    ______________________________________

    IN THIS WEEK'S ISSUE

    »  News

        --  New Labeling Warns of Heart-Related Risks with Diabetes Drug Avandia 

    --  FDA Announces Measures to Strengthen Its Advisory Committee Process 

    --  Agency Awards Grants to Further Safety of the National Food Supply 

    --  About $2 Million Worth of Potentially Harmful Eye Product Seized  

»  Congressional Testimony 

»  Upcoming Public Meetings 

              »  Consumer Health Information 

                __________________________________________ 

                NEWS

                New Labeling Warns of Heart-Related Risks with Diabetes Drug Avandia

                  FDA has announced that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug's labeling about potential increased risk for heart attacks. Avandia was approved in 1999 to be used with diet and exercise to improve control of blood sugar levels.

                  http://www.fda.gov/bbs/topics/NEWS/2007/NEW01743.html

                  FDA Announces Measures to Strengthen Its Advisory Committee Process

                  FDA is taking several steps to bolster its advisory committee process. The measures include proposed new guidance or procedures on advisory committee voting, on disclosing information on conflicts of interest, and on security and appropriate conduct for participants at meetings. 

                  http://www.fda.gov/bbs/topics/NEWS/2007/NEW01744.html

                  Agency Awards Grants to Further Safety of the National Food Supply

                  FDA is awarding three lab grants, designed to boost food-screening capabilities and spot radioactive material in food that results from deliberate or accidental contamination. The three-year grants provide $250,000 a year for supplies, personnel, minor facility upgrades and training. 

                  http://www.fda.gov/bbs/topics/NEWS/2007/NEW01747.html 

                  About $2 Million Worth of Potentially Harmful Eye Product Seized 

                  U.S. marshals have seized more than 12,000 applicator tubes of Age Intervention Eyelash, a product that may, in some users, lead to decreased vision. Authorities said the sales value of the seized tubes is approximately $2 million. Age Intervention Eyelash is sold and distributed by Jan Marini Skin Research Inc., of San Jose, Calif. FDA considers the product to be an unapproved and misbranded drug. 

                  http://www.fda.gov/bbs/topics/NEWS/2007/NEW01746.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.]

                  ___________________________________________

                  CONGRESSIONAL TESTIMONY

                  Nov. 14 -- FDA Director of Science and Health Coordination Norris Alderson, Ph.D., appeared before the House Subcommittee on Domestic Policy.

                      Subject: dental amalgams

                  http://www.fda.gov/ola/2007/dentalmercury111407.html

                  To view an archive of past testimony by FDA officials, go to 

                  http://www.fda.gov/ola/listing.html

_____________________________________________ 

                      UPCOMING PUBLIC MEETINGS 

                      Nov. 27-29 -- Pediatric Advisory Committee

                          Under discussion: adverse event reports related to the drug Tamiflu (Nov. 27-28); labeling of drugs for lactating women (Nov. 29)

                          Location: Gaithersburg, Md.

                      ›  Nov. 27-28: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-20302.htm

                      ›  Nov. 29: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-20304.htm

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

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

                        CONSUMER HEALTH INFORMATION

                        Each week in FDA News Digest, we will spotlight consumer health information by offering links to timely articles about FDA activities and products the agency regulates.

                        Here's what's in the spotlight this week:

                        › Food Safety Tips for Healthy Holidays

                        http://www.fda.gov/consumer/updates/foodsafetytips111307.html 

                        › Precautions to Prevent Rabies

                        http://www.fda.gov/consumer/updates/rabiesvaccine102207.html 

                            If you would like to sign up to receive all consumer updates, go to http://www.fda.gov/consumer/consumerenews.html  

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