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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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Fast Track Action Committee on Biosafety and Biosecurity (FTAC)
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA, OS
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OD/OSP, NIAID
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Examines relevant biosafety regulations and further explores options for enhancing biosafety oversight.
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FDA Acute Radiation Syndrome (ARS) Action Team
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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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The purpose of this collaboration is to inform members of the Food and Drug Administration (FDA) Acute Radiation Syndrome (ARS) Action Team on key data from the radiation and nuclear countermeasures program (RNCP) drug development portfolio that will inform them in advancing products that may be brought forward for eventual licensure. A biweekly meeting takes place between the National Institute of Allergy and Infectious Diseases (NIAID) (RNCP/Program Officer) and FDA(OCET/Senior Advisor) Senior Advisor to decide which medical countermeasures (MCMs) will be presented to the Action Team.
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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 the Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (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 the National Cancer Institute''s (NCI) Cancer Centers, presentation and discussion of specific new molecular imaging modalities, and discussion of recent FDA decisions regarding newmedical imaging innovations.
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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 Substance Registry System Public Interface
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Resource Development
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FDA
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NLM
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The National Library of Medicine (NLM) and the Food and Drug Administration (FDA) established a collaborative effort to provide an interface for public access to the FDA’s Substance Registration System (SRS). The FDA SRS utilizes an existing NLM database backend architecture to provide public search capability for FDA substances and medicinal products.
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FDA Uterine Fibroids Working Group
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Committee, Work group, Advisory group, or Task Force
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FDA
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NICHD, OD/DPCPSI/ORWH
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The Uterine Fibroids Working Group is one working group of the Women’s Health Clinical Research Network (WH-CRN) that focuses specifically on the treatment of fibroids. The WH-CRN seeks to meet the growing demand for evidence that better reflects the patient experience during routine care by creating a coordinated registry network (CRN) that uses structured data capture and HL7 FHIR to efficiently extract, standardize, and exchange data from electronic health records and link registries and other data sources to cover a number of technologies in clinical areas unique to women.
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FDA/NIH Interagency Clinical Outcomes Assessments Working Group Meeting
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIMH, NCCIH, NCI, NHLBI, NIAMS, NINDS
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The Food and Drug Administration (FDA) and Institute representatives from the National Institutes of Health (NIH) meet periodically to discuss the development of valid patient-oriented treatment outcomes, and relative measurements, for use in clinical trials of therapeutic interventions.
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Federal Consortium on the Substance Abusing Offender
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Committee, Work group, Advisory group, or Task Force
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SAMHSA
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NIDA
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Coordination of approximately a dozen agencies that work with substance abusing offenders. Staff meet by phone quarterly to provide updates on projects and initiatives at their agencies at the intersection of substance use and justice.
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Federal Dietary Reference Intakes Steering Committee
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Committee, Work group, Advisory group, or Task Force
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AHRQ, CDC, FDA, OS
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NIDDK, NHLBI, OD/DPCPSI/ODS
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This Dietary Reference Intakes subcommittee reports to the Interagency Committee on Human Nutrition Research (ICHRN) to provide oversight on the process used to establish the Dietary Reference Intakes. These values serve as a basis for many federal nutrition programs and policies.
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