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European-US Pediatric Formulations Excipients Committee
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Other
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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.
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Evaluate the Efficacy of an Antiviral Drug
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Research Initiative
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CDC
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NICHD
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The purpose of this Intra-agency Agreement (IAA) is to establish a formal working relationship between CDC and NICHD as co-sponsors of a multicenter clinical study to evaluate the efficacy of an antiviral drug, tenofovir, for prevention of hepatitis B virus (HBV) mother-to-child transmission from HBV-infected mothers with high HBV viral load. The study evaluates the critical issue of prevention of mother-to-child transmission (MTCT) of HBV in the high risk situation of elevated maternal HBV virus load [HBV e antigen positive (HBeAf+] mothers). Infants infected at birth with HBV are at high risk of both cirrhosis and liver cancer during adulthood.
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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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Evidence-based Methodology Workshop on Polycystic Ovary Syndrome
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Meeting/ Workshop
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AHRQ
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OD/DPCPSI/ODP, NICHD
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The Office of Disease Prevention coordinates the development of Evidence-based Methodology Workshops (EbMW) that seek to identify methodological and scientific weaknesses in a scientific area and move the field forward through an unbiased and evidence-based assessment of a complex clinical issue. The first workshop in this program focused on polycystic ovary syndrome, a common hormone disorder that affects approximately 5 million reproductive-aged women in the United States. The workshop was designed to clarify: 1) benefits and drawbacks of using the Rotterdam Criteria, 2) the condition’s causes, predictors, and long-term consequences, and 3) optimal prevention and treatment strategies. The workshop was sponsored by the Office of Disease Prevention and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. A multidisciplinary steering committee developed the workshop agenda. The NIH Library created an extensive, descriptive bibliography on PCOS to facilitate workshop discussion. During the 2½-day workshop, invited experts discussed the body of evidence and attendees provided comments during open discussion periods. After weighing the evidence, an unbiased, independent panel prepared a report that summarized the workshop and identified future research priorities. The workshop was held on December 3-5, 2012.
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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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Family Health History
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Health Survey
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OSG
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NCI, NHGRI
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The "My Family Health Portrait" tool is a Web-enabled program that runs on any computer that is connected to the Web and running an up-to-date version of any major Internet browser. The Web-based tool helps users organize family history information and then print it out for presentation to their family doctor. In addition, the tool helps users save their family history information to their own computer and even share family history information with other family members.
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FDA /Cancer Diagnosis Program (CDP) monthly meeting
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Other
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FDA
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NCI
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Participants discuss proposed integral markers and process for regulatory input into integral markers/assays for clinical trials.
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FDA Arthritis Drugs Advisory Committee Meeting
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA
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NIMH
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An NIMH Program Officer was invited to serve as a voting ad hoc member of one of the FDA''s standing advisory committees, which met to review a new drug application for the treatment of Chronic Fatigue Syndrome.
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FDA Blood Products Advisory Committee
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA
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OD/OSP, CC, NHLBI
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The FDA Blood Products Advisory Committee advises the FDA regarding issues of blood safety and efficacy. The committee reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood, products derived from blood and serum, or biotechnology which are intended for use in the diagnosis, prevention, or treatment of human diseases.
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