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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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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 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 NIMH Program Officer (PO) was invited to serve as a voting ad hoc member of one of the FDA Arthritis Drugs Advisory Committees, which met to review a new drug application for the treatment of Chronic Fatigue Syndrome (CFS). Subsequently, the NIMH PO has been invited as the sole NIH representative to a follow-up meeting planned at the FDA among FDA staff, a CDC representative, and the sponsor to discuss further steps in Myalgic Encephalomyelitis/CFS drug development.
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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 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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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 Cancer Imaging Program (CIP) Bi-annual Meeting
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Meeting/ Workshop
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FDA
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NCI
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This collaboration is a bi-annual meeting to enhance communication between the Cancer Imaging Program (CIP) and the Division of Medical Imaging Products of CDER in the FDA. This allows for a two-way exchange of information and discussion of issues that are important for each side. Topics that have been discussed include CIP''s standardization efforts of medical imaging scanners in NCI Cancer Centers, presentation and discussion of specific new molecular imaging modalities, and discussion of recent FDA decisions regarding new medical imaging innovations.
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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 Drug Safety Oversight Board
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Committee, Work group, Advisory group, or Task Force
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AHRQ, CDC, CMS, FDA, HRSA, IHS
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OD/OSP, NCI
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The FDA Drug Safety Oversight Board (DSB), created in 2005 and mandated by law in the FDA Amendments Act of 2007, advises the FDA''s Center for Drug Evaluation and Research (CDER) Center Director on the handling and communicating of important and often emerging drug safety issues and regulatory science. The DSB is composed of representatives from two FDA Centers and eight other federal government agencies: the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS), Department of Defense (DOD), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), and Department of Veterans Affairs (VA). An important role of the DSB is to help FDA assess the impact of their safety decisions on the healthcare systems of its Federal Partners. The Board, with its broad representation from federal healthcare organizations, can provide valuable input and allows FDA to hear other perspectives on drug safety issues.
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