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Memorandum of Understanding (MoU) between FDA/Center for Drug Evaluation and Research (CDER) and NIH/NINDS
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Other
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FDA
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NINDS
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This MoU provides a mechanism for addressing cross-cutting issues related to drug evaluation and research for neurological disorders, from bench science to clinical studies and the Food and Drug Administration (FDA) approval.
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Memorandum of understanding (MOU) between NIDA and the FDA Center for Devices and Radiological Health
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Other
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FDA
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NIDA
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Will Aklin leads a memorandum of understanding (MOU) between NIDA and the FDA Center for Devices and Radiological Health which was established in 2019 and reissued in 2024. The MOU allows regular interaction and sharing of information regarding digital therapeutics and device-based treatments. MOU goals also include developing guidance to grant applicants to help navigate the FDA submission and authorization process and accelerate the progression of these technologies through the regulatory pathway.
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Memorandum of Understanding (MOU) between the FDA Center for Devices and Radiological Health and NIH/NINDS
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Other
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FDA
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NINDS
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This MOU provides a mechanism for addressing cross-cutting issues related to the development of devices for neurological disorders, from bench science to clinical studies and the Food and Drug Administration (FDA) approval.
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Memorandum of Understanding (MOU) between the FDA/Center for Biologics Evaluation and Research (FDA/CBER) and NIH/NINDS
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Other
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FDA
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NINDS
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This MoU provides a mechanism for addressing cross-cutting issues related to therapy development for neurological disorders, from bench science to clinical trials and the Food and Drug Administration (FDA) approval and licensure.
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Microphysiological Systems for Drug Efficacy and Toxicity Testing (Tissue Chip for Drug Screening)
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Research Initiative
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ASPR, FDA
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NCATS, NCI, NEI, NHLBI, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCR, NIDDK, NIEHS, NIGMS, NINDS, NINR, OD/DPCPSI/ORWH, OD/DPCPSI/OSC
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The Microphysiological systems (MPS) initiative aims to develop 3-D human tissue chips that accurately model the structure and function of human organs, such as the lung, liver, and heart. Researchers are currently using these models to predict whether a candidate drug, vaccine, or biologic agent is safe or toxic in humans in a faster and more cost-effective way than current methods. More than 30 percent of promising medications have failed in human clinical trials because they are determined to be toxic despite promising pre-clinical studies in animal models. These organs-on-chips will also enable scientists to predict more accurately how effective a therapeutic candidate would be in clinical studies. To help streamline the therapeutic development pipeline, NIH, in collaboration with the US Food and Drug Administration (FDA) and the Innovation and Quality (IQ) Consortium of pharmaceutical companies, is leading this initiative to improve the process for predicting whether drugs will be safe and effective in humans. In an effort to overcome some clinical trial challenges, Clinical Trials on a Chip is supporting the development of tissue chips to inform clinical trial design for both common and rare diseases; support the planning and execution of clinical trials; assist in patient stratification; help identify reliable clinical trial endpoints; and ultimately develop tools for more informative and efficient clinical trials for both common and rare diseases. Another program, the Tissue Chips in Space initiative, is creating tissue- and organ-on-chip platforms that can be sent to the ISS National Lab so that scientists can better understand the role of microgravity on human health and diseases and translate those findings to improve human health on Earth. Current efforts aim to bring tissue chips towards FDA regulatory qualification as drug development tools by establishing Translational Centers for MPS.
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Mind Your Risks
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Public Education Campaign
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CDC, CMS
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NHLBI, NIA, NINDS
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The Mind Your Risks campaign is designed to create awareness and action about the fact that risk factors for stroke, particularly hypertension, may be linked to cognitive impairment and dementia.
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Mine Safety and Health Research Advisory Committee
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Committee, Work group, Advisory group, or Task Force
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CDC
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NIEHS
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The Mine Safety and Health Research Advisory Committee shall advise the Secretary, HHS; the Director, Centers for Disease Control and Prevention (CDC); and the Director, National Institute for Occupational Safety and Health (NIOSH), CDC, on the conduct of mine health research, including making of grants and entering into contracts for such research (30 U.S.C. §812(b)(2), [Section 1 02(b )(2) of Public Law 91-173]). The committee shall also provide advice on the conduct of mine safety research. The committee shall evaluate the degree to which: 1) the mine research activities of NIOSH conform to those standards of scientific excellence appropriate to Federal scientific instructions in accomplishing objectives in mine safety and health; 2) the mine research activities, alone or in conjunction with other known activities inside and outside of NIOSH, address currently relevant needs in the field of mine safety and health; and 3) the research activities produce intended results in addressing important research questions in mine safety and health, both in terms of applicability of the research findings and translation of the findings.
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Molecular Approaches To Antiviral Development For Viral Hepatitis and Other Viral Diseases
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Research Initiative
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IHS
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NIDDK
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Molecular Approaches To Antiviral Development For Viral Hepatitis and Other Viral Diseases
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Molecular Foundations for Biotechnology: Partnerships to Transform Emerging Industries – RNA Tools/Biotechnology, NSF 23-554
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Research Initiative
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Not Reported
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NHGRI
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The 2023 MFB solicitation was released in partnership with NHGRI and focuses on RNA. The program aims to support projects that pursue creative, technological approaches to study RNA function in complex biological systems and harness RNA research to advance biotechnology. The goal is to catalyze synergies among the biological, chemical, computational, mathematical, and physical sciences.
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Molecular Profiling of Diabetes and its Complications
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Research Initiative
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IHS
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NIDDK
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Molecular Profiling of Diabetes and its Complications
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