FDA News & Notes – Week of February 6, 2012
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 Meeting discusses 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 the bones. 8 a.m., 10903 New Hampshire Avenue, Building 31, Room 1503, Silver Spring, Md.
Press Office Contact: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
Thursday, 2/9 – The Oncologic Drugs Advisory Committee Meeting discusses a supplemental new drug application for Dacogen (decitabine) to treat patients with acute myelogenous leukemia in people ages 65 years or older who are not considered candidates for induction chemotherapy. 8 a.m., 10903 New Hampshire Avenue, Building 31, Room 1503, Silver Spring, Md.
Press Office Contact: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Thursday, 2/9 – The House Committee on Energy and Commerce, Subcommittee on Health holds a hearing on generic drug and biosimilar user fees and drug shortages. 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, karen.riley@fda.hhs.gov
Thursday, 2/9 – The Anesthetic and Analgesic Drug Products Advisory Committee discusses the efficacy and safety data for supplemental new drug application for QUTENZA (capsaicin 8%) Patch by NeurogesX Inc. for proposed indication of management of HIV-related nerve pain. 8:30 a.m., DoubleTree by Hilton Hotel Washington DC/Silver Spring, 8727 Colesville Road, Silver Spring, Md.
Press Office Contact: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Friday, 2/10 – The Neurological Devices Panel of the Medical Devices Advisory Committee makes recommendations regarding the possible reclassification of cranial electrotherapy stimulator devices. Hilton Washington DC North/Gaithersburg, 620 Perry Parkway, Gaithersburg, Md.
Press Office Contact: Michelle Bolek, 301-796-2973, michelle.bolek@fda.hhs.gov
Friday, 2/10 – The Cellular, Tissue and Gene Therapies Advisory Committee meets by teleconference, in open session, to consider updates of the research programs in the Cellular and Tissue Therapy Branch, Office of Cellular, Tissue and Gene Therapies, at the FDA’s Center for Biologics Evaluation and Research. Those attending must be onsite. 2 p.m., National Institutes of Health, 9000 Wisconsin Avenue, Building 29B, Conference Room A-B, Bethesda, Md.
Press Office Contact: Rita Chappelle, 301-796-4672, rita.chappelle@fda.hhs.gov
FDA Office of Public Affairs Contact Information:
Call or email FDA Office of Public Affairs, 301-796-4540, fdaopa@fda.hhs.gov
List of FDA Press Officers and beats
More Resources:
SOURCE U.S. Food and Drug Administration