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Emergency Preparedness, Medical Countermeasures
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Resource Development
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OS
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NCI
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The National Cancer Institute (NCI) provides expertise in radiation biology and radiation oncology to help guide the research and development of medical countermeasures for radiation injury and for biomarkers for assessing injury, dose, and who needs treatment.
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End-stage Renal Disease (ESRD) Collaboration
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Committee, Work group, Advisory group, or Task Force
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CMS, FDA
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NIDDK, NIBIB
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Participating agencies and patient and physician groups are collaborating to help the medical product development community to understand the challenges and milestones needed to achieve the goal of a successful alternative to dialysis. Research, regulatory, and reimbursement needs for such a product are discussed in phone calls and structured meetings.
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Endocrinologic and Metabolic Drugs 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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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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In October 2009, the Food and Drug Administration (FDA), the National Eye Institute (NEI), and the Department of Defense (DoD) launched the LASIK Quality of Life Collaboration Project (LQOLCP) to help better understand the potential risk of severe problems that can result from LASIK. The project published three manuscripts in 2016 on the new questionnaire developed by the group that can be used to assess the percent of patients who develop difficulties performing their usual activities following LASIK, and to identify predictors for those patients.
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Extracellular Ribonucleic Acid (RNA) Communication
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Research Initiative
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FDA
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OD/DPCPSI/OSC, NCATS
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Recent advances have indicated that ribonucleic acids (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 have coordinated efforts on the preclinical and clinical use of exRNAs to address human health and disease. To date, several PIs have had pre-pre-IND meetings with FDA/CBER. They have been provided information necessary to submit applications, for example, a biomarkers device.
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Extracting Adverse Reactions and Indexing the Content of Structured Product Labels (SPLs)
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Resource Development
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FDA
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NLM
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The objective of this initiative is for the National Library of Medicine (NLM) to assist the US Food and Drug Administration (FDA) in indexing the content of structured product labels (SPL) for drugs. Natural language processing technology is used to extract drug-drug interaction information from SPLs which will be validated by FDA subject matter experts. Transforming the narrative text to structured information encoded in national standard terminologies is a prerequisite to the effective deployment of drug safety information in drug labels for clinical decision support. Starting in FY16, the Labeling and Health Communication (LHC) and the FDA''s Center for Drug Evaluation and Research (CDER) collaborate on advancing automated extraction of Adverse Reactions (ARs) from drug listing information companies have submitted to FDA in the form of Structured Product Labels (SPLs). The goals of the initial agreement were to develop optimal MetaMap settings for extracting ARs from SPLs and provide FDA with the software necessary to replicate the results. To evaluate the extraction quality, LHC and FDA needed to develop a test collection of SPLs annotated with ARs. Working together, LHC and FDA have developed annotation guidelines. LHC have annotated 200 SPLs and coded the results to MedDRA, the official controlled vocabulary used by FDA to normalize the labeled ARs. In FY18, the collaboration continues with the goals to conduct a community-wide evaluation of the available AR extraction tools. The evaluation venue is NIST Text Analysis Conference (TAC). Over 130 new labels have been annotated with DDIs in FY18.
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Eye Research Collaboration
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Other
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FDA
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NEI
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The National Eye Institute (NEI) is collaborating with the Food and Drug Administration (FDA) on uveitis research and on the ocular manifestations of Zika virus and Ebola virus. Uveitis is an autoimmune disease that targets the eye. If left untreated the disease can cause permanent vision loss. Current treatments consist of steroids to suppress the immune system. However, chronic use of these drugs has many side-effects and complications. Recent outbreaks of Ebola virus and Zika virus have highlighted the unique immunological responses to these infections in the “immune privileged” eye. The virus persists in ocular fluids, even after virus is cleared from other parts of the body.
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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 dissiminate the consensus research hemophilia community. In so doing, the strategic priorities for future 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 MCMs will be presented to the Action Team.
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