SILVER SPRING, Md., Feb. 6, 2012 /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 February 6, 2012.
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FDA News & Notes does not contain any regulatory or enforcement actions due to legal limitations.
Meetings, Workshops and Congressional Testimony:
Wednesday, 2/8 – The Oncologic Drugs Advisory Committee opens a two-day meeting with a discussion on a supplemental biologics application for Xgeva (denosumab) to treat men with castrate-resistant prostate cancer who are at high risk of developing bone metastases or have had their cancer spread to their bones. On Thursday morning the committee discusses a supplemental new drug application for Dacogen (decitabine) to treat patients with acute myelogenous leukemia in people ages 65 years and older who are not considered candidates for induction chemotherapy. The afternoon session focuses on a new drug application for Pixuvri (pixantrone dimaleate) for use as a single agent treatment in patients with relapsed or difficult to treat aggressive non-Hodgkin's lymphoma who received two or more prior lines of therapy. 8 a.m., 10903 New Hampshire Avenue, Building 31, Room 1503, Silver Spring, Md.
Press Office Contact: Erica Jefferson, 301-796-4988, [email protected]
Thursday, 2/9 – The House Committee on Energy and Commerce, Subcommittee on Health holds a committee hearing on generic drug and biosimilar user fees. Drug shortages will also be discussed. Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research is scheduled to testify. 10 a.m., 2123 Rayburn House Office Building, Washington, D.C.
Press Office Contact: Karen Riley, 301-796-4674, [email protected]
Thursday, 2/9 – The Anesthetic and Analgesic Drug Products Advisory Committee discusses the available efficacy and safety data for a supplemental new drug application for Qutenza (capsaicin 8%) Patch, by NeurogesX Inc., for the use of management of nerve pain related to HIV-associated peripheral neuropathy (such as nerve pain in the feet and legs). 8:30 a.m., Double Tree by Hilton Hotel, Washington DC/Silver Spring, 8727 Colesville Road., Silver Spring, Md.
Press Office Contact: Morgan Liscinsky, 301-796-0397, [email protected]
Friday, 2/10 – The Neurological Devices Panel of the Medical Devices Advisory Committee makes recommendations regarding the possible reclassification of cranial electrotherapy stimulator (CES) devices. The discussion includes the existing data to support CES safety and effectiveness and whether the data are sufficient to develop special controls to support regulation of these devices under Class II. 8 a.m., Hilton Washington DC North/Gaithersburg, Salons A, B, C and D, 620 Perry Parkway, Gaithersburg, Md.
Press Office Contact: Michelle Bolek, 301-796-2973, [email protected]
Friday, 2/10 – The Cellular, Tissue and Gene Therapies Committee meets to hear updates and discuss, by teleconference, a report of the site visit to observe intramural research conducted by the Gene and Tissue Therapy Branch of the FDA's Center for Biologics Evaluation and Research. Attendees must be present. 2 p.m., Building 29B, Conference Room A-B, National Institutes of Health, 9000 Wisconsin Avenue, Bethesda, Md.
Press Office Contact: Rita Chappelle, 301-796-4672, [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
SOURCE U.S. Food and Drug Administration
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