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FDA News & Notes - Week of May 16, 2011

Monday, May 16, 2011 General News J E 4
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SILVER SPRING, Md., May 16, 2011 /PRNewswire-USNewswire/ -- Science, public health, and regulatory highlights for this week from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of May 16, 2011.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations.

Events and Speeches for the Commissioner and FDA leadership:

Tuesday, 5/17 – FDA Commissioner Margaret Hamburg, M.D., will speak on "Ensuring Global Food Safety through International Regulatory Cooperation" at the Asian Pacific Economic Cooperation's (APEC) Food Safety Cooperation Forum in Big Sky, Mont. A copy of the Commissioner's speech will be available upon request.

Press Office Contact: Doug Karas, 301-796-2805, douglas.karas@fda.hhs.gov

Wednesday, 5/18 – Commissioner Hamburg will provides remarks at a Memorandum of Understanding signing between the APEC and the World Bank, Food Safety Cooperation Forum. The two organizations will work collaboratively to improve the food safety capabilities of APEC member economies through training and the sharing of best practices and lessons learned. http://www.apec2011.gov/index.htm.  

Press Office Contact: Doug Karas, 301-796-2805, douglas.karas@fda.hhs.gov

Thursday, 5/19 – FDA Deputy Commissioner for Foods Mike Taylor will deliver a major policy address on the core principle of the new FDA Food Safety Modernization Act, prevention, and how it has been embraced by the public health community and the food industry as the key to effective food safety reform. 1 p.m., George Washington University, Jack Morton Auditorium, 805 21st Street, NW, Washington D.C.

Press Office Contact: Doug Karas, 301-796-2805, douglas.karas@fda.hhs.gov

Meetings, Workshops and Congressional Testimony:

Monday, 5/16 – The Pediatric Advisory Committee will discuss pediatric-focused safety reviews for a number of products as well as discuss Topical Calcineurin Inhibitors Elidel and Protopic. 8 a.m., Hilton Hotel, 8727 Colesville Road, Silver Spring, Md.

Press Office Contact: Jeff Ventura, 301-796-2807, jeffrey.ventura@fda.hhs.gov

Tuesday, 5/17 and Wednesday, 5/18 – Joint Meeting of Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee will review the safety and effectiveness of current over-the-counter acetaminophen dosing standards in children under 2 years of age and those between 2 and 12. 8 a.m., Hilton Hotel, 8727 Colesville Road, Silver Spring, Md.

Press Office Contact: Jeff Ventura, 301-796-2807, jeffrey.ventura@fda.hhs.gov

Tuesday, 5/17 – Learn about FDA's global inspection program during a 30-minute webinar. Question and answer segment following the presentation. 12:30 p.m. Webinar slides are posted online.

Thursday, 5/19 – Endocrinologic and Metabolic Drugs Advisory Committee will discuss the findings of the Action to Control Cardiovascular Risk in Diabetes-Lipid trial as they relate to the efficacy and safety of the approved new drug application for TRILIPIX (fenofibric acid) delayed release capsules. 8 a.m., Hilton Hotel, 8727 Colesville Road, Silver Spring, Md.Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov

Friday, 5/20 – Science Board Advisory Committee Meeting will discuss the report from the subcommittee's review of the Pharmacovigilance Program at the Center for Drug Evaluation and Research. The board will be provided with updates on FDA's nanotechnology research program plans and Comparative Effectiveness Research. Background materials should be available at least two business days before the meeting. 9 a.m., 10903 New Hampshire Ave., Bldg. 31, Room 1503, Silver Spring, Md.

Press Office Contact: Jeff Ventura, 301-796-2807, jeffrey.ventura@fda.hhs.gov

FDA Office of Public Affairs Contact Information:Call or email FDA Office of Public Affairs, 301-796-4540, fdaopa@fda.hhs.gov

List of FDA press officers and beatsMore Resources:FDA News and Events

FDA Photos  (Flickr)

Consumer Health Information

SOURCE U.S. Food and Drug Administration

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