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Evaluation of Visual Function in Animal Models
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Research Initiative
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FDA
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NEI
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Evaluation of Visual Function in Animal Models
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Evidence-Based Cancer Control Programs (EBCCP)
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Resource Development
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CDC
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NCI
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The Evidence-based Cancer Control Programs website is a searchable database of cancer control interventions and program materials and is designed to provide program planners and public health practitioners easy and immediate access to research-tested materials.
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Extracorporeal CPR (ECPR) for Out-of-hospital Cardiac Arrest
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Meeting/ Workshop
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OASH
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NHLBI
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Workshop to evaluate the gaps and barriers in clinical research needed to expedite understanding and targeting of the restoration of cardiovascular status to improve survival after OHCA with eCPR, to identify the state of the science and regulatory policy for eCPR with ECMO-facilitated OHCA, and to discuss future opportunities to facilitate the advancement of clinical research while identifying approaches to developing effective eCPR therapies.
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Factor VIII Inhibitors: Generating a National Blueprint for Future Research
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Meeting/ Workshop
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CDC
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NHLBI, NCI, NICHD, NLM
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A State of the Science meeting was planned and executed on May 15-16, 2018 in collaboration with the national and international hemophilia community. The national and international hemophilia community. The details of the planning effort, the proceedings and work of 4 working groups, and the synthesized research blueprint have been submitted to the journal Haemophilia blueprint have been submitted to the journal Haemophilia as a series of 6 papers that are currently under review. Once published they will disseminate the consensus research hemophilia community. In so doing, the strategic priorities for future National Heart, Lung, and Blood Institute (NHLBI) funding in this field were better defined.
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FDA Antimicrobial Drugs Advisory Committee (FDA AMDAC)
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIAID
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Discuss new drug application (NDA) 215596, for maribavir oral tablets, submitted by Takeda Pharmaceuticals USA, Inc., for the treatment of adults with post-transplant cytomegalovirus infection and/or disease, including infections resistant and/or refractory to ganciclovir, valganciclovir, cidofovir, or foscarnet.
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FDA CDER & NIH NCATS Regulatory Fitness in Rare Disease Clinical Trials Workshop
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Meeting/ Workshop
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FDA
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NCATS
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On May 16 and 17, 2022, the FDA Center for Drug Evaluation and Research (CDER) and NCATS hosted a jointly sponsored virtual workshop on regulatory fitness in rare disease clinical trials. Rare disease drug development represents an area of high unmet medical need. This workshop focused on academic investigators and those looking to learn how to bridge the gap between academic investigation and the regulatory aspects of drug development. The workshop provided lessons on the fundamentals of drug development and included discussion of rare disease case studies shared by academic investigators; shared experiences and expertise from multi-disciplinary stakeholders; discussed regulatory considerations for rare disease clinical trials; and discussed topics such as Adequate and Well-Controlled Trials, Core Principles for Clinical Trials, The Nuts and Bolts of Investigational New Drug (IND) Applications and Additional Considerations, Additional Pathways to Interact with the FDA CDER, and case studies.
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FDA Collaboration - Psilocybin Research
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Research Initiative
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FDA
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CC
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The group is working on research that might gauge the effectiveness of psilocybin for pain management and use in other facets of palliative care.
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FDA Microbiology Devices Panel of the Medical Devices Advisory Committee
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIAID
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This Committee provides expertise in the evaluation of evidence submitted by pharmaceutical companies to the Food and Drug Administration (FDA) for drug approval.
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FDA-NCI Quarterly Meeting
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Meeting/ Workshop
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FDA
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NCI
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This Quarterly meeting to enhance communication between NCI DCTD/CTEP and FDA, thereby expediting the development of new anti-cancer agents. General topics discussed include patient safety, clinical efficacy, and regulatory pathways to licensure, as well as an understanding of the operations of the sister agencies. Since NCI DCTD/CTEP acts as the official regulatory sponsor of IND studies performed in the ETCTN, and selected studies in the NCTN, PBTC, and PEP-CTN, these quarterly meetings are important to ensure NCI DCTD/CTEP is performing its regulatory responsibilities in compliance with regulations and the dialogue with the FDA also helps in exploring new ways to enhance patient safety and clinical trial monitoring in a risk-based approach. The Quarterly meeting dates each year are discussed and scheduled in consultation with the FDA depending on the availability of appropriate FDA staff for the particular issue that will be discussed. NCI and FDA staff have a meeting usually 1 month prior to the next anticipated Quarterly Meeting in order to decide on topics that will be discussed.
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FDA-NIH Joint Leadership Council
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Committee, Work group, Advisory group, or Task Force
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FDA
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OD/OSP, NCI, NHLBI, NIAID, NIDA, NIDDK, NINDS, OD/IMOD, OD/OER
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Facilitates leadership-level development of mutual priorities between both Department of Health and Human Services (HHS) operating divisions.
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