SILVER SPRING, Md., Nov. 14, 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 November 14, 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:
Tuesday, 11/15 – FDA Commissioner Hamburg delivers keynote address at a conference titled "FDA at a Crossroads," co-sponsored by the Union of Concern Scientists, the FDA, and George Washington University. 9 a.m., Jack Morton Auditorium, George Washington University, Washington, D.C. Event will be webcast. Agenda.
Press Office Contact: Morgan Liscinsky, 301-796-0397, [email protected]
Meetings, Workshops and Congressional Testimony:
Tuesday, 11/15 – The full Senate Health, Education, Labor, and Pensions Committee holds a hearing titled Medical Devices: Protecting Patients and Promoting Innovation. 2:30 p.m., 430 Dirksen Senate Office Building, Washington, D.C.
Press Office Contact: Karen Riley, 301-796-4674, [email protected]
Wednesday, 11/16 – The Gastrointestinal Drugs Advisory Committee discusses design of clinical trials to evaluate the safety, efficacy, and durability of response with repeat treatment cycles of Xifaxan (rifaximin) by Salix Pharmaceuticals Inc. 8 a.m., Holiday Inn Washington/College Park, 10000 Baltimore Ave., The Ballroom, College Park, Md.
Press Office Contact: Morgan Liscinsky, 301-796-0397, [email protected]
Wednesday, 11/16 – The Vaccines and Related Biological Products Advisory Committee discusses and makes recommendations on the safety and immunogenicity of Pneumoccocal 13-valent conjugate vaccine in people ages 50 and older using an accelerated approval regulatory pathway. 8 a.m., Hilton Washington DC/ Silver Spring, 8727 Colesville Road, Silver Spring, Md.
Press Office Contact: Shelly Burgess, 301-796-4651, [email protected]
Thursday, 11/17 – The Gastrointestinal Drugs Advisory Committee provides recommendations on the design and size of premarketing cardiovascular safety development programs needed to support approval of serotonin (5-hydroxytryptamine) receptor 4 (5HT4) agonists for the proposed indications of chronic idiopathic constipation, constipation predominant irritable bowel syndrome, gastroparesis, and gastroesophageal reflux disease that does not respond to a proton pump inhibitor. 8 a.m., Holiday Inn Washington/College Park, 10000 Baltimore Avenue, The Ballroom, College Park, Md.
Press Office Contact: Morgan Liscinsky, 301-796-0397, [email protected]
Thursday, 11/17 – The Risk Communication Advisory Committee begins a two-day meeting with a discussion of results of a literature review about communicating quantitative risk and benefit information in prescription drug promotional labeling and print advertising. The committee also will hear a presentation on the FDA's Office of Special Health Issues. On Friday, the committee discusses strategic communication and recent theoretical developments on information used in decision-making. 8 a.m., 10903 New Hampshire Avenue, Building 31, Room 1503, Silver Spring, Md.
Press Office Contact: Sandy Walsh, 301-796-4669, [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:
FDA News and Events
CONTACT: Raymond Formanek Jr. 301-796-4677
SOURCE U.S. Food and Drug Administration
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