December 1 - 2, 2009
National Cancer Advisory Board
National Cancer Institute
Bethesda, MD
The agenda includes an NCI Director's report, an update from the American Association for Cancer Research, and an interim report from the Operational Efficiency Working Group on clinical trials.
December 1 - 2, 2009
Recombinant DNA Advisory Committee
National Institutes of Health
Bethesda, MD
The Committee will review and discuss selected human gene transfer protocols as well as related data management activities. Additional discussions include an update on a trial that used a lentiviral vector for beta-thalassemia and sickle cell disease and a discussion of proposed final changes to the NIH Guidelines for Research Involving Recombinant DNA to address synthetic nucleic acids.
December 4, 2009
Advisory Committee to the Director
National Institutes of Health
Bethesda, MD
Among the topics proposed for discussion are: (1) NIH Director's Report; (2) NIH Director's Council of Public Representatives Liaison Report; and (3) other business of the Committee.
December 9, 2009
President’s Cancer Panel Meeting - U.S. Demographic and Cultural Transformation:Implications for the Cancer Enterprise
President's Cancer Panel
Wilmington, DE
Immigration, more than any other social/political/economic process, has shaped the U.S. over the last century. Minorities, now roughly one-third of the U.S. population, are expected to become the majority in 2042, with the nation projected to be 54 percent minority in 2050. Questions addressed at this conference include: Does the clinical encounter differ across ethnic groups? To what extent do patients and providers contribute to health disparities? Are there beliefs (or stereotypes) held by providers about the behavior or health of ethnic sub-populations? Do patients from ethnic sub-populations experience, understand, and discuss illness differently than mainstream populations? Do patients from ethnic sub-populations have different help-seeking behavior?
December 11, 2009
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee
Food and Drug Administration
Gaithersburg, MD
The committee will discuss and make recommendations on the study designs and endpoints of clinical investigations intended to support approval or clearance of devices indicated for the primary treatment of localized prostate cancer.
December 15, 2009
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
Food and Drug Administration
Gaithersburg, MD
The subcommittee will consider and discuss: (1) FDA expectations regarding the development of pediatric formulations for cancer drugs, and (2) the development of dosing regimens in infants and toddlers with cancer.
December 16, 2009
Oncologic Drugs Advisory Committee
Food and Drug Administration
Gaithersburg, MD
The committee will discuss supplemental new drug application (sNDA) 021- 743/S-016, TARCEVA (erlotinib) tablets, by OSI Pharmaceuticals, Inc. The proposed indication (use) for this product is first-line maintenance, monotherapy (first-choice, single drug) treatment in patients with a form of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (has spread regionally within the lung and/or within chest lymph nodes) or metastatic (has spread beyond the lung), and who have not progressed (including those patients with stable disease) on first-line treatment with platinum-based chemotherapy (a regimen including a platinum drug (cisplatin or carboplatin) plus another chemotherapy drug). During the afternoon session, the committee will discuss supplemental new drug application (sNDA) 022-059/S-007, TYKERB (lapatinib) tablets, by SmithKline Beecham Ltd. doing business as GlaxoSmithKline. The proposed indication (use) for this product is in combination with an aromatase inhibitor for the treatment of hormone sensitive advanced or metastatic breast cancer.
December 17, 2009
Oncologic Drugs Advisory Committee
Food and Drug Administration
Gaithersburg, MD
The committee will discuss new drug application (NDA) 022-555, proposed trade name HEXVIX (hexaminolevulinate as hydrochloride) Kit, for the preparation of HEXVIX solution for intravesical use, by Photocure ASA. The product is a diagnostic imaging agent that becomes visible when illuminated by blue light, a special type of light that causes the agent to appear a certain (fluorescent) color. The agent is proposed for administration into the bladder to help in the examination of the bladder wall with a cystoscope, a surgical instrument used to detect some types of cancer. The proposed indication (use) for this product is for blue light cystoscopy performed with the Karl Storz Photodynamic Diagnosis (PDD) system (equipment that produces blue light) as an adjunct to white light cystoscopy in the detection of non-muscle invasive papillary cancer of the bladder.
January 25, 2010
National Mammography Quality Assurance Advisory Committee
Food and Drug Administration
Gaithersburg, MD
The committee will discuss guidance documents issued since the last meeting. The committee will also receive updates on: Interventional mammography accreditation programs, recently approved alternative standards, facility inspection findings, the status of current inspection followup actions, and the radiological health program.
March 25, 2010
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
Food and Drug Administration
Gaithersburg, MD
The committee will review and discuss recent information, including recent literature regarding the possible risks to the general public from intentional exposure to ultraviolet radiation (UV) from use of tanning lamps. There continues to be a growing body of literature showing association of skin cancer with use of tanning lamps and the committee will discuss this information and other information related to the association of UV and skin cancer (both melanoma and non-melanoma). The committee will be asked to recommend whether changes to current classification or current regulatory controls of UV emitting devices (lamps) used for tanning are needed.
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