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FDA News & Notes - Week of July 18, 2011
Date:7/18/2011

SILVER SPRING, Md., July 18, 2011 /PRNewswire-USNewswire/ -- Science, public health, and regulatory highlights 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 July 18, 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:
Monday, 7/25 – FDA Commissioner Margaret A. Hamburg discusses consumer and pharmaceutical issues as part of Public Citizen's 40th Anniversary Speaker Series Symposium. 12:30 p.m., 1600 20th Street, N.W., Washington, D.C. Send required RSVP to bholzer@citizen.org.
Press Office Contact: Raymond Formanek Jr., 301-796-4677, raymond.formanek@fda.hhs.gov

Meetings, Workshops and Congressional Testimony:
Wednesday, 7/20 – The Circulatory System Devices Panel of the Medical Devices Advisory Committee discusses and votes on information related to the premarket approval application for the Edwards SAPIEN Transcatheter Heart Valve sponsored by Edwards Lifesciences. 8 a.m., Hilton Washington D.C. North/Gaithersburg, 620 Perry Parkway, Gaithersburg, Md.
Press Office Contact: Amanda Sena, 301-796-0393, amanda.sena@fda.hhs.gov

Wednesday, 7/20 – Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee  discusses the drug development program of an investigational gastroenterology drug. Meeting is open to the public from 8 a.m. to 9 a.m. From 9 a.m. to 1 p.m., the meeting will be closed for discussion and review of trade secret and confidential commercial information. Hilton Washington, D.C./Silver Spring, 8727 Colesville Rd., Silver Spring, Md.
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov

Thursday, 7/21 – The Circulatory System Devices Panel of the Medical Devices Advisory Committee discusses and votes on the humanitarian device exemption for the Berlin Heart EXCOR Pediatric Ventricular Assist Device sponsored by Berlin Heart Inc. 8 a.m., Hilton Washington D.C. North/Gaithersburg, 620 Perry Parkway, Gaithersburg, Md.
Press Office Contact: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov

Thursday, 7/21 – Gastrointestinal Drugs Advisory Committee Meeting to discuss results from a clinical trial of supplement biologics license application 103772/5301, Remicade (infliximab), Centocor Ortho Biotech Inc., in the treatment of pediatric patients with moderately to severely active ulcerative colitis. 8 a.m., Hilton Washington, D.C./Silver Spring, 8727 Colesville Rd., Silver Spring, Md.
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov

Thursday, 7/21 – The Tobacco Products Scientific Advisory Committee meets to discuss changes proposed to the TPSAC Menthol Report submitted to the agency on March 18, 2011, and additional oral and written comments from the public. During an afternoon session, the committee discusses the nature and impact of the use of dissolvable tobacco products on the public health. 8 a.m., Center for Tobacco Products, 9200 Corporate Boulevard, Rockville, Md. The meeting will be webcast. See the CTP website for information.
Press Office Contact: Jeff Ventura, 301-796-2807, jeffrey.ventura@fda.hhs.gov

Friday, 7/22 – The Tobacco Products Scientific Advisory Committee continues its discussion of the nature and impact of the use of dissolvable tobacco products on the public health. 8 a.m., Center for Tobacco Products, 9200 Corporate Boulevard, Rockville, Md. The meeting will be webcast. See the CTP website for information.
Press Office Contact: Jeff Ventura, 301-796-2807, jeffrey.ventura@fda.hhs.gov

On the Web:
FDA Commissioner Hamburg announces a new agency initiative to encourage development of domestic medical products during a July 15, 2011, appearance at the City Club of Cleveland. Podcast available here.

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 beats

More Resources:
FDA News and Events
FDA Photos (Flickr)
Consumer Health Information


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SOURCE U.S. Food and Drug Administration
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