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FDA News & Notes - Week of July 25, 2011

SILVER SPRING, Md., July 25, 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 25, 2011.


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, 7/26 – FDA Commissioner Margaret Hamburg speaks at the amfAR Capitol Hill Summit held to mark the progress that has been made in the fight against the disease. 1 p.m., Kennedy Caucus Room (R-325), Russell Senate Office Building, Constitution Ave. and Delaware Ave., N.E., Washington, D.C. Space is limited. RSVP to or call 703-288-8696.
Press Office Contact: Raymond Formanek Jr., 301-796-4677,

Meetings, Workshops and Congressional Testimony:
Tuesday, 7/26 – The FDA's Pharmaceutical Science and Clinical Pharmacology Advisory Committee discusses bioequivalence and quality standards for narrow therapeutic index drug products. 8 a.m., 10903 New Hampshire Ave., Building 31, Room 1503, Silver Spring, Md.
Press Office Contact: Sandy Walsh, 301-796-4669,

Wednesday, 7/27 – The FDA's Pharmaceutical Science and Clinical Pharmacology Advisory Committee considers strategies for the implementation of quality by design principles within the Office of Pharmaceutical Science review offices. 8 a.m., 10903 New Hampshire Ave, Building 31, Room 1503, Silver Spring, Md.
Press Office Contact: Sandy Walsh, 301-796-4669,

Wednesday, 7/27 – American Telemedicine Association Policy Summit
Bakul Patel, policy adviser, and Mary Brady, senior policy analyst, from the Center for Devices and Radiological Health speak on mobile health policy and telehealth. 8:30 a.m., The Westin Washington, D.C., 1400 M Street, N.W., Washington, D.C.
Press Office Contact: Karen Riley, 301-796-4674,

Thursday, 7/28 – FDA Commissioner Hamburg testifies before the Senate Committee on Health, Education, Labor and Pensions on "FDA User Fees: Advancing Public Health." 9:45 a.m., Dirksen Senate Office Bldg., Constitution Ave. and 1st St., N.E., Room 430, Washington, D.C.
Press Office Contact: Karen Riley, 301-796-4674,

Monday, 8/1 –  The first FDA Humanitarian Use Device Workshop provides an opportunity to spend two days developing applications for devices intended to treat or diagnosis a rare disease or condition. 8 a.m., University of Minnesota-Twin Cities Campus, Moos Tower, 515 Delaware Street, S.E., Minneapolis.
Press Office Contact: Sandy Walsh, 301-796-4669,

On the Web:
Tuesday, 7/26 – The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, "Recalls Pending Classification: DRUGS." They will be reposted with their classification once that determination has been made. Send comments or suggestions to
Press Office Contact: Shelly Burgess, 301-796-4651,

Analysis of Premarket Review Times Under the 510(k) Program at Center for Devices and Radiological Health.
Press Office Contact: Karen Riley, 301-796-4674,

Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses
Press Office Contact: Erica Jefferson, 301-796-4988,

FDA Office of Public Affairs Contact Information:
Call or email FDA Office of Public Affairs, 301-796-4540,
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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