FDA News & Notes - Week of September 12, 2011

Sep 12, 2011, 15:13 ET from U.S. Food and Drug Administration

SILVER SPRING, Md., Sept. 12, 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 September 12, 2011.

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

Meetings, Workshops and Congressional Testimony:
Tuesday, 9/13 – Second day of a two-day Public Workshop on Mobile Medical Applications Draft Guidance, for medicine and health care apps designed for smartphones and other mobile computing devices. 8 a.m., 10903 New Hampshire Ave., Building 31, Room 1503, Silver Spring, Md. The meeting will be webcast.
Press Office Contact: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov

Tuesday, 9/13 –Second day of the Unique Device Identification (UDI) for Postmarket Surveillance and Compliance Public Workshop on the adoption, implementation, and use of UDIs in health-related electronic data systems. 9 a.m., Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road., Bethesda, Md. The workshop will be webcast.
Press Office Contact Jeff Ventura, 301-796-2807, jeffrey.ventura@fda.hhs.gov

Tuesday, 9/13 – Ted Elkin, director of Food Defense, Communications, and Emergency Response at CFSAN, testifies as part of a panel on Agro-Defense: Responding to Threats Against America's Agriculture and Food System before the Subcommittee on Oversight of Government Management, the Federal Workforce, and the District of Columbia, Senate Committee on Homeland Security and Governmental Affairs. 2:30 p.m., Dirksen Senate Office Building, Room SD-628, Washington, D.C.
Press Office Contact: Patricia El-Hinnawy, 301-796-4763, patricia.el-hinnawy@fda.hhs.gov

Tuesday, 9/13 – Quarantine Release Errors (QREs) in Blood Establishments Public Workshop to provide FDA and industry with information to reduce the rates of QREs. 8:30 a.m., The Universities at Shady Grove Conference Center 9630 Gudelsky Drive, Building II, Multipurpose Room, Rockville, Md.
Press Office Contact: Rita Chappelle, 301-796-4672, rita.chappelle@fda.hhs.gov

Wednesday, 9/14 – The Oncologic Drugs Advisory Committee discusses Ferriprox a treatment for patients with transfusional iron overload when chelation therapy is inadequate. In the afternoon, the committee discusses products for the treatment of patients with non-metastatic castration resistant prostate cancer. 8 a.m.., 10903 New Hampshire Ave., Building 31, Room 1503, Silver Spring, Md. The meeting will be webcast.
Press Office Contact: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov

Friday, 9/16 – Public Meeting: Recommendations Proposed in Institute of Medicine Report: Medical Devices and the Public's Health, The FDA 510(k) Clearance Process at 35 Years. Public comments accepted on the recommendations proposed in the IOM report. 8:30 a.m., Hilton Hotel, 8727 Colesville Road, Silver Spring, Md. The meeting will not be webcast.
Press Office Contact: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov

Friday, 9/16 – Public Workshop on the Development and Evaluation of Next-Generation Smallpox Vaccines. 8 a.m., Hilton Washington D.C. North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, Md.
Press Office Contact: Rita Chappelle, 301-796-4672, rita.chappelle@fda.hhs.gov

Monday, 9/19 – 2011 PDA/FDA Joint Regulatory Conference and TRI Courses. The FDA and Parenteral Drug Association cosponsor a three-day public conference to explore strategies and approaches for facilitating development and improvement of safe and effective medical products. 7 a.m., Renaissance Hotel, 999 Ninth St., N.W., Washington, D.C.
Press Office Contact: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov

On the Web:
Overview of Regulatory Requirements: Medical Devices – video, slides, transcript in Spanish
Press Office Contact: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov

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

Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Humanitarian Use Devices
Press Office Contact: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov

Letter to Industry about Import Entry Review Process –9/6/11
Press Office Contact: Karen Riley, 301-796-4674, karen.riley@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



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