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Peripheral and Central Nervous System Drugs Advisory Committee
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Committee, Work group, Advisory group, or Task Force
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FDA
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CC
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Ad hoc member of the Committee. January 20 2011, meeting to consider an NDA for Florbetapir F 18 injection for use in PET imaging of beta-amyloid in the brain.
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Personal Motion Technologies for Healthy Independent Living
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Meeting/ Workshop
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CMS, FDA
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NIBIB, NCATS, NIA, NICHD, NINDS, OD
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Support the development and translation of high-impact home-based technology systems for health. This includes viable integrated systems using standards and common platforms for diagnosis, monitoring, screening, and intervention as well as studies to prove the effectiveness/efficacy of personal health technologies for people with disabilities, aging adults, and people with chronic disease.
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Pharmacist Education in the Era of Genomic Medicine Meeting
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Meeting/ Workshop
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CDC, HRSA
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NHGRI, NCI
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The Genomic Healthcare Branch, NHGRI, hosted a meeting of all the major U.S. pharmacy organizations in Rockville, Md., to discuss the current landscape of pharmacist education in genomics and determine priorities for genomics education of the profession.
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Phenylketonuria (PKU) Scientific Workshop
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Meeting/ Workshop
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AHRQ, FDA, HRSA
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OD, NHGRI, NICHD, NIDDK, NINDS, NINR
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In October 2000, the NIH published a Consensus Development Conference Statement for screening and management of PKU. Since then, new treatments, including pharmacological, have emerged. To assist clinicians in making treatment decisions, NIH has revisited the guidelines. Five working groups were convened to explore an expanded body of literature and address important questions regarding treatment of PKU. These working groups will present their findings during the conference on February 22-23, 2012.
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Pillbox
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Resource Development
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FDA
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NLM
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The National Library of Medicine and the Food and Drug Administration have established a collaborative relationship to enhance patient safety through the linking of digital images of prescription solid dosage form medications to the Structured Product Labeling (SPL) files and the substance information of those pharmaceuticals.
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Pilot Workshop on Behavioral and Social Sciences Research: Engaging Patients and Providers in Patient-Centered Primary Care
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Meeting/ Workshop
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CMS
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OD
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This co-sponsored research workshop provided an opportunity for CMS staff to learn about patient-provider communications and the impact of incentives in patient and provider behavior from NIH-funded research on these topics. Three researchers discussed their work and its implications within the context of CMS demonstrations related to the patient-centered medical home, but their findings have broad applicability to other demonstrations and initiatives aimed at engaging providers and patients in specific behaviors.
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Planning Committee for the Annual Conference of the African American Healthy Marriage Initiative (AHMI) - Planning Committee for the Annual Conference
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Meeting/ Workshop
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ACF, SAMHSA
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NIDA, NIMH
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The mission of the African American Healthy Marriage Initiative (AAHMI) is to promote and strengthen the institution of healthy marriage in the African American community. The Administration for Children and Families has partnered with national, civic and community organizations to develop a strategy directed toward increasing child well-being and strengthening families by promoting healthy marriages.
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Planning Committee to Outline Guidelines for the Conduct of Biomedical Prevention Intervention Research During Pregnancy
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA
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OD/DPCPSI/OAR, NIAID, NICHD, OD
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A collaborative group that planned meetings and developed guidelines to outline a safe step-wise approach to conducting biomedical prevention intervention research during pregnancy.
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Pluripotent Stem Cells in Translation: Early Decisions
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Meeting/ Workshop
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FDA
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NINDS, CC, NCI, NHLBI, NIAID, NIAMS, NIBIB, NIDCR, OD
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The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are organizing a series of workshops that will engage the broader research community regarding requirements necessary for translation of pluripotent stem cell-derived products into the clinic. The first workshop, held March 2011, focused on establishment of stem cell lines and banks, covering safety and regulatory issues related to how the original cell line derivation is done in the case of embryonic stem cells, and how the cells are reprogrammed in the case of iPS cells. The second workshop, to be held July 10-11, 2012, will focus on preclinical safety and proof of concept testing, including, among other topics, clinical relevance of the animal models, selection of cell dose levels, impact of host microenvironment, and cell fate post-administration. A third, and final, workshop is expected to focus on clinical trial design including safety monitoring, immunogenicity, immunosuppressant use and immune monitoring.
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Polyhalogenated Aromatic Hydrocarbons (PHAH) and Thyroid Cancer
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Research Initiative
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CDC
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NCI
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PHAHs are being measured in banked serum/plasma samples from cohort studies to evaluate the association with thyroid cancer incidence.
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