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Executive Committee for Acquisitions
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Committee, Work group, Advisory group, or Task Force
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ASFR, ACF, ASPR, CDC, FDA, HRSA
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OD/OM, OD/OM/OALM
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The Executive Committee for Acquisitions meets under the leadership of the HHS Senior Procurement Executive (SPE) and includes all the Heads of Contracting Activities from the various HHS Operating Divisions. The purpose is to receive policy updates and collaborate on acqusiition related issues.
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FDA Center for Drug Evaluation (CDER)/NIDA Division of Therapeutics and Medical Consequences (DTMC)
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIDA
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Collaboration between the FDA Center for Drug Evaluation (CDER)/NIDA Division of Therapeutics and Medical Consequences (DTMC).
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FDA Device Workgroup
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIMH
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This workgroup provides ongoing dialogue with the FDA related to devices and mHealth.
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FDA Medical Imaging Drugs Advisory Committee
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Committee, Work group, Advisory group, or Task Force
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FDA
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CC, NCI
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The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology and makes appropriate recommendations to the Commissioner of Food and Drugs. https://www.fda.gov/advisory-committees/human-drug-advisory-committees/…
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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-NIA collaboration on FDA's Medical Device Development Tool program
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Research Initiative
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FDA
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NIA
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The objective of this collaboration is to stimulate the participation of small businesses in the FDA's Medical Device Development Tools (MDDT) program. This collaboration led to developing a contract topic entitled DIGITIAL TECHNOLOGIES AS TOOLS TO DIAGNOSE AND MONITOR ALZHEIMER’S DISEASE (AD) AND RELATED DEMENTIAS (ADRD). This contract topic was recently approved in the May National Advisory Council on Aging meeting. The goal of this topic is to develop and demonstrate the utility of digital technologies as a measure of AD/ADRD screening and monitoring as qualified MDDTs to assess medical devices subject to regulation by FDA's Center for Devices and Radiological Health.
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FDA-NIH Clinical Research Working Group
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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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The use of clinical research terminology describing innovative designs and operational approaches has been inconsistent and ambiguous. Work Group activities include 1) analyzing current clinical design characteristics 2) defining a taxonomy of clinical research design characteristics 3) defining terms in acompanion glossary
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FDA-NIH Joint Agency Nutrition Working Group (JAN)
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Committee, Work group, Advisory group, or Task Force
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FDA
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NCI, NICHD, NINR, OD/DPCPSI/ONR, OD/OSP
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The Joint Agency Nutrition (JAN) was established to address gaps and opportunities in the areas of dietary supplements and nutrition research related to pregnant women and children and chronic diseases. The Working Group reports to the NIH-FDA Joint Leadership Council.
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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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NCI, NEI, NHLBI, NIDA, NIMH, NINDS, NLM, OD/DPCPSI, OD/IMOD, OD/OER, OD/OSP
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The FDA-NIH JLC is a collaborative committee to identify and address clinical trial policy issues, programs, and research initiatives of mutual interest
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FDA-NIMH Points of Contact Working Group Meeting - Drugs
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Committee, Work group, Advisory group, or Task Force
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FDA
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NIMH
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Food and Drug Administration (FDA) and National Institute of Mental Health (NIMH) representatives meet quarterly to discuss issues of mutual interest related to the development and clinical trials of pharmacologic therapeutic interventions.
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