SILVER SPRING, Md., June 20, 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 June 20, 2011.
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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, 6/22 – FDA Commissioner Margaret A. Hamburg speaks at the Pacific Health Summit: Lunch Conversation: Balancing Safety, Innovation, and Speed. 3:30 p.m. (Eastern Daylight Time), Bell Harbor International Conference Center, Harbor Dining Room, 2211 Alaskan Way, Seattle, Wash.
Press Office Contact: Raymond Formanek Jr., 301-796-4677, [email protected]
Meetings, Workshops and Congressional Testimony:
Tuesday, 6/21 – Arthritis Advisory Committee discusses supplemental biologics license application for ILARIS (canakinumab), proposed for treatment of gouty arthritis. 8:30 a.m., The Marriott Inn & Conference Center, University of Maryland University College, 3501 University Blvd. East, Hyattsville, Md.
Press Office Contact: Morgan Liscinsky, 301-796-0397, [email protected]
Wednesday, 6/22 – Senate Committee on Homeland Security and Governmental Affairs. Charles Zimliki, Ph.D., chairman of the Artificial Pancreas Critical Path Initiative, testifies on Transforming Lives through Diabetes Research. 1:30 p.m., Dirksen Senate Office Building, Room SDG-50, Washington, D.C.
Press Office Contact: Karen Riley, 301-796-4674, [email protected]
Thursday, 6/23 – The Pulmonary-Allergy Drugs Advisory Committee discusses new drug application for icatibant solution for injection for treatment of acute attacks of hereditary angioedema. 8:30 a.m., Hilton Washington, D.C./Silver Spring, 8727 Colesville Road, Silver Spring, Md.
Press Office Contact: Morgan Liscinsky, 301-796-0397, [email protected]
Thursday, 6/23 – FDA Deputy Commissioner for Foods Michael Taylor, industry officials, and representatives from two Mexican government agencies – the Federal Commission for the Protection against Sanitary Risk and the National Service of Agro-Alimentary Health, Safety, and Quality – discuss implementation of the Food Safety Modernization Act. 3:45 p.m. (Eastern Daylight Time), Sheraton Maria Isabel Hotel and Towers, Paseo de la Reforma, 325 Col. Cuauhtemoc, Duque Room, Mexico City, Mexico. A press conference follows roundtable discussion at 6 p.m. (Eastern Daylight Time).
Press Office Contact: Doug Karas, 301-796-2805, [email protected]
Thursday, 6/23 – FDA Workshop: Ultra-High Throughput Sequencing for Clinical Diagnostic Applications – Approaches To Assess Analytical Validity. Assessment of analytical performance for ultra-high throughput genomic sequencing-based clinical applications. 8 a.m., 10903 New Hampshire Ave., Bldg. 31, Room 1503, Silver Spring, Md., Register to attend or view the webcast.
Press Office Contact: Erica Jefferson, 301-796-4988, [email protected]
On the Web:
Press Office Contact: Erica Jefferson, 301-796-4988, [email protected]
Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics. Draft guidance for companies developing treatments for non-small cell lung cancer on clinical endpoints to support effectiveness claims in new drug, biologics and supplemental applications.
Press Office Contact: Erica Jefferson, 301-796-4988, [email protected]
FDA Office of Public Affairs Contact Information:
Call or email FDA Office of Public Affairs, 301-796-4540, [email protected]
List of FDA press officers and beats
More Resources:
SOURCE U.S. Food and Drug Administration
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