SILVER SPRING, Md., April 11, 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 April 11, 2011.
FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations.
Meetings, Workshops and Congressional Testimony:
Tuesday, 4/12 – Oncologic Drugs Advisory Committee meets to discuss a supplemental drug application for Afinitor (everolimus) tablets to treat patients with advanced neuroendocrine tumors of gastrointestinal, lung, or pancreatic origin. During the afternoon session, the committee will discuss Sutent (sunitinib malate) capsules to treat unresectable pancreatic neuroendocrine tumors. 8 a.m., FDA, 10903 New Hampshire Ave., Room 1503, White Oak Conference Center, Bldg. 31, Silver Spring, Md.
Wednesday, 4/13 – House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations. FDA Commissioner Margaret Hamburg, M.D., will testify on "Import Safety: Status of FDA's Screening Efforts at the Border" and Predictive Risk-based Evaluation for Dynamic import Compliance Targeting. 10:30 a.m., 2123 Rayburn House Office Building, Washington, D.C.
Thursday, 4/14 – The House Committee on Oversight & Government Reform, Subcommittee on Health Care, District of Columbia, Census and the National Archives. FDA Center for Devices and Radiological Health Director Jeffrey Shuren, M.D., expected to testify on the "Pathway to FDA Medical Device Approval: Is There a Better Way?" 1:30 p.m.,Room 2247, Rayburn House Office Building, Washington, D.C.