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European-US Pediatric Formulations Excipients Committee
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Committee, Work group, Advisory group, or Task Force
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FDA
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NICHD
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Multinational academic, industry, and regulatory group convened to determine toxicity of excipients in pediatrics. Accomplishments include developing a database that will be tested both in the EU and US this year
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Evaluation of Patient Reported Outcomes Following LASIK Surgery
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Research Initiative
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FDA
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NEI
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This will be a prospective, questionnaire-based study conducted by the U.S. Navy Refractive Surgery Center San Diego in collaboration with the U.S. Food and Drug Administration’s Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices. The primary purpose is to quantify the satisfaction and health related quality of life of 500 active duty patients over a period of six months following state-of-the-art laser in situ keratomileusis (LASIK). The questionnaire to be used will be a new instrument which, once validated in this study, might be employed in future clinical studies that include civilian refractive surgery centers in the U.S.
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Evaluation of the Evidence to Support Guidelines for Nutritional Care of Preterm Infants: "The Pre-B Project"
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Meeting/ Workshop
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CDC, FDA
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NICHD
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To address the lack of accepted standards for nutritional care of preterm infants, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)—in collaboration with a consortium of professional organizations and relevant agencies—organized this effort to conduct systematic reviews of existing evidence and to develop guidelines related to nutrition in preterm infants. The Evaluation of the Evidence to Support Guidelines for the Nutritional Care of Preterm Infants: The Pre-B Project, is modelled in approach after the B-24 project, an NICHD-led effort to include evidence on infants from birth to age 24 months in the Dietary Guidelines for Americans. Working Groups were charged with identifying: Priority topics and questions for which there is sufficient evidence to conduct systematic reviews that result in a grading and guideline development process; and a targeted research agenda to address those priority areas for which no/insufficient evidence exists to support guideline development. Working Groups addressed the following themes: Nutrient specifications for preterm infants (including limits of viability up to near-term babies and an analysis of all essential nutrients) Issues in feeding preterm infants with particular emphasis on factors influencing the transition to enteral feeding Care of specific clinical conditions commonly found in neonatal intensive care units, including preterm and sick term infants (Examples of conditions would include necrotizing enterocolitis or bronchopulmonary dysplasia) Standards of existing and new guidelines, including current standards for outcomes such as growth and neurological development.
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Evidence-Based Review & Report Program
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Resource Development
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AHRQ
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OD/DPCPSI/ODP, NCCAM
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This Congressionally mandated program reviews current scientific evidence on the efficacy and safety of dietary supplements; identifies research needs; and prepares reports of their findings.
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Exposure Assessment of Engineered Nanoparticles
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Research Initiative
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CDC
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NIEHS
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The purpose of this project is to identify workplaces engaged in the synthesis, manufacture and use of engineered nanomaterials, and to characterize the potential for worker exposure to selected engineered nanoparticles.
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Extracellular RNA Communication
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Research Initiative
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FDA
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OD/DPCPSI, NCATS, OD/DPCPSI/OSC
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Recent advances have indicated that RNAs can play a role in a variety of complex cellular functions, including newly discovered mechanisms of cell-to-cell communication. RNA can be exported from cells in extracellular vesicles or bound to lipids or proteins, to circulate through the body and affect cells at a distance. However, the actual impact of the extracellular RNAs, or exRNAs, is currently unknown. NIH and FDA intend to collaborate and coordinate efforts towards the preclinical and clinical use of exRNAs to address human health and disease.
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Eye Research Collaboration
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Other
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FDA
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NEI
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National Eye Institute (NEI) investigator Rachel Caspi is collaborating with Drs. Daniela Verthelyi and Raymond Donnelly of the Food and Drug Administration (FDA) on uveitis research. Uveitis is an autoimmune disease that targets the eye. If left untreated the disease can cause permanent vision loss. Current treatments consist of steroids to suppress the immune system. However, chronic use of these drugs has many side-effects and complications.
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Family Health History
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Health Survey
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CDC, HRSA, OS, OSG
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NCI, NHGRI, NLM
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Family history is a key factor in risk for many diseases, including common conditions such as diabetes, heart disease, and cancer. Awareness of health conditions within a family may prompt members to take precautions to lower their risk, improve quality of life, and possibly extend their life. Family health history can guide health care providers'' recommendations. Thus, My Family Health Portrait was developed, redesigned, and is maintained to help people organize their family’s health histories. Plus, stakeholders convene bi-monthly for updates and networking in regards to family history.
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Family Planning, Preconception Care, and Safer Conception for Men and Women with HIV Curriculum Advisory Group
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Committee, Work group, Advisory group, or Task Force
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CDC, HRSA, OS
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OD/DPCPSI/OAR
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Primary target audience is HIV and primary care providers and the group was convened to write a curriculum on Family Planning, Preconception Care and Safer Conception for Men and Women with HIV
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FDA Arthritis Drugs Advisory Committee Meeting
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Meeting/ Workshop
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CDC, FDA
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NIMH
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An National Institute of Mental Health (NIMH) Program Officer (PO) was invited to serve as a voting ad hoc member of one of the Food and Drug Administration (FDA) Arthritis Drugs Advisory Committee, which met to review a new drug application for the treatment of Chronic Fatigue Syndrome (CFS). Subsequently, in FY2014 the NIMH PO was invited as the sole NIH representative to a follow-up meeting at the FDA, led by the Director of the FDA Center for Drug Evaluation and Research among FDA staff, a CDC representative, the sponsor, and patient/consumer representatives to discuss further steps in Myalgic Encephalomyelitis/CFS drug development.
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