Published: December 05, 2011

FDA News & Notes - Week of December 5, 2011

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SILVER SPRING, Md., Dec. 5, 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 December 5, 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:

Wednesday, 12/7 - Life Science Alley's 10th Annual Conference and Expo. Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, delivers the keynote speech at the conference with the theme of "Advancing Medical Technology." 3:45 p.m., Minneapolis Convention Center, 1301 2nd Avenue South, Minneapolis.
Press Office Contact: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov

Thursday, 12/8 - Deputy FDA Commissioner Stephen Spielberg, M.D., Ph.D., Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research, and John Jenkins, M.D., director of the Office of New Drugs, Center for Drug Evaluation and Research, are among the speakers at the two-day FDA/CMS Summit. Agenda. The Mayflower Renaissance, 1127 Connecticut Avenue, N.W., Washington, D.C.
Press Office Contact: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov

Meetings, Workshops and Congressional Testimony:

Wednesday, 12/7 - First day of a two-day Circulatory System Devices Panel Meeting to make recommendation and vote on information related to a supplement to the premarket approval application for Medtronic, Inc's Cardiac Resynchronization Therapy Defibrillator devices and CardioMEMS's HF Pressure Measurement System. 8 a.m., Hilton Washington D.C. North/Gaithersburg, 620 Perry Parkway, Salons A, B, C, and D, Gaithersburg, Md.
Press Office Contacts: Sandy Walsh, 301-796-4669; sandy.walsh@fda.hhs.gov
Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov

Thursday, 12/8 - The Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee meet in joint session to discuss the benefits and risks of drospirenone-containing oral contraceptives and the emerging risk of blood clots that can break loose and move within the circulatory system. 8 a.m., Marriott Inn and Conference Center, University of Maryland University College, 3501 University Boulevard East, Hyattsville, Md.
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov

Thursday, 12/8 - National Academies of Science-Beebe Symposium - Start of two-day discussion on tracking radiation exposure from medical diagnostic procedures. 8 a.m., 500 Fifth Street N.W., Room 100, Washington, D.C.
Press Office Contact: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov

Friday, 12/9 - The Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee meet in joint session to discuss the benefits and risks of Ortho Evra (norelgestromin/ethinyl estradiol transdermal system) for the prevention of pregnancy. Specifically, the committees will discuss the possible increased risk of blood clots that can break loose and move within the circulatory system in users of Ortho Evra compared with women who use prescribed birth control pills, as suggested by postmarketing studies. 8 a.m., Marriott Inn and Conference Center, University of Maryland University College, 3501 University Boulevard East, Hyattsville, Md.
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov

On the Web:

Summary Information for Belotero Balance and Consumer Information on Belotero Balance dermal fillers to fill in facial wrinkles in order to create a smoother appearance.
Press Office Contact: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov

Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses
Press Office Contact: Erica Jefferson, 301-796-4988, erica.jefferson@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 beats

More Resources:

FDA News and Events

FDA Photos (Flickr)

Consumer Health Information

SOURCE U.S. Food and Drug Administration