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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 Review & Report Program
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Committee, Work group, Advisory group, or Task Force
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AHRQ, FDA
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OD, 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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Evidence Based Review - Probiotic Safety
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Other
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AHRQ, FDA
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NCCAM, OD
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In 2008, the ODS, NCCAM and FDA/CFSAN initiated a systematic review through the AHRQ to evaluate the evidence for safety of probiotics. The collaboration has consisted of intellectual exchange of knowledge expertise and appropriate guidance during monthly teleconferences.
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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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Family History Initiative
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Public Education Campaign
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AHRQ, CDC, HRSA, IHS, OS, OSG, SAMHSA
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NHGRI, NCI
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Collaborative initiative to promote public and health care provider awareness and use of family History as a tool for health care. The activity has also served as a very important driver of work on developing interoperability of health information technology systems and clinical decision support tools. Has included the development and continued enhancement of the U.S. Surgeon General''s My Family Health Portrait family history web tool.
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Family Smoking Prevention and Tobacco Control Act National Longitudinal Study
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Research Initiative
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FDA
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NIDA, NCI, NHLBI, NICHD, NIEHS, OD
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This longitudinal study aims to evaluate the behavioral and health impact of the 2009 Family Smoking Prevention and Tobacco Control Act, which gives the FDA authority to regulate tobacco products.
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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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NHLBI, CC
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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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FDA Cancer Diagnosis Program (CDP) Monthly Meeting
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Committee, Work group, Advisory group, or Task Force
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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 Center of Drug Evaluation and Research (CDER) Workgroup
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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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The joint CC-CDER collaborative working team is aimed at developing new processes to consider exceptions to existing CDER policies and procedures for extraordinary clinical circumstances. Over the past few years, CC investigators have encountered instances in which regulatory barriers may have precluded novel pharmacological interventions for severely ill patients. Leaders at the FDA CDER became aware of the concern of some NIH intramural investigators and approached CC leadership to understand the issues.
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FDA Clinical Pharmacology Review Rotation
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Training Initiative
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FDA
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CC
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The fellow typically completes a 6 week rotation at the FDA in the Office of Clinical Pharmacology in the Center for Drug Evaluation and Research (CDER). The fellow participates in the review of INDs and supplemental NDAs, including the evaluation of new clinical PK protocols, study reports etc. The fellow will take the lead on 1-2 key assignments, representing clinical pharmacology in interdisciplinary team meetings and writing the final clinical pharmacology report.
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