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FDA News & Notes - Week of May 9, 2011

Tuesday, May 10, 2011 Drug News J E 4
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SILVER SPRING, Md., May 9, 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 9, 2011.

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

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

Meetings, Workshops and Congressional Testimony:

Monday, 5/9 and Tuesday, 5/10 – International Consortium of Orthopaedic Registries; Public Workshop. Discussion of a strategic plan to establish a distributed consortium of U.S. and international registries of orthopaedic procedures and devices. 8 a.m., 10903 New Hampshire Ave., Bldg. 31, Room 1503, Silver Spring, Md.

Press Office Contact: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov

Tuesday, 5/10 – Generic Drug User Fee public meeting. Updates and an opportunity to gather additional input on the development of a generic drug user fee program. 2 p.m., 10903 New Hampshire Ave., Bldg. 1, Room 4101, Silver Spring, Md.

Press Office Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov

Wednesday, 5/11 – The Pediatric Ethics Subcommittee of the Pediatric Advisory Committee discusses the ethics of administering subtherapeutic doses of investigational products to children. 8 a.m., North Marriott & Conference Center, 5701 Marinelli Road, Bethesda, Md.

Press Office Contact: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov

Thursday, 5/12 – The Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee discusses and votes on information about a premarket approval application for the Augment Bone Graft, an alternative bone grafting substitute to autologous bone graft. 8 a.m., Hilton Washington D.C. North/Gaithersburg, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, Md.

Press Office Contact: Amanda Sena, 301-796-0393, amanda.sena@fda.hhs.gov

Thursday, 5/12 – FDA sponsors public workshop: Study Methodologies for Diagnostics in the Postmarket Setting. 8:30 a.m., 10903 New Hampshire Ave., Bldg. 31, Room 1503, Silver Spring, Md.

Press Office Contact: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov

Notes:

Avastin Meeting – The FDA has granted a hearing to Genentech Inc. on 6/28 and 6/29 to discuss the Center for Drug Evaluation and Research's proposal to withdraw approval of the breast cancer indication for Avastin (bevacizumab). Space will be limited. Register early to attend the hearing at 10903 New Hampshire Ave., Bldg. 31, Room 1503, Silver Spring, Md., or to view a real-time webcast.

Press Office Contacts: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov (logistics)

Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov (product data and status)

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

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