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FDA Blood Product Advisory Committee
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Committee, Work group, Advisory group, or Task Force
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CDC, FDA
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NHLBI, CC
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The Food and Drug Administration (FDA) Blood Products Advisory Committee advises the FDA regarding issues of blood safety and efficacy. The committee reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood, products derived from blood and serum or biotechnology which are intended for use in the diagnosis, prevention, or treatment of human diseases.
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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 CDER in the 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 NCI Cancer Centers, presentation and discussion of specific new molecular imaging modalities, and discussion of recent FDA decisions regarding new medical imaging innovations.
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FDA Center of Drug Evaluation and Research (CDER) Workgroup
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Committee, Work group, Advisory group, or Task Force
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FDA
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CC
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The joint collaborative between the NIH Clinical Center (CC) and the FDA Center of Drug Evaluation and Research (CDER) Workgroup is aimed at developing new processes to consider exceptions to existing CDER policies and procedures for extraordinary clinical circumstances. Over the past few years, CC investigators have encountered instances in which regulatory barriers may have precluded novel pharmacological interventions for severely ill patients. Leaders at the FDA CDER became aware of the concern of some NIH intramural investigators and approached CC leadership to understand the issues.
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FDA Drug Safety Oversight Board
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Committee, Work group, Advisory group, or Task Force
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AHRQ, CDC, CMS, FDA, HRSA, IHS
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OD/OSP, NCI
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The FDA Drug Safety Oversight Board (DSB), created in 2005 and mandated by law in the FDA Amendments Act of 2007, advises the FDA''s Center for Drug Evaluation and Research (CDER) Center Director on the handling and communicating of important and often emerging drug safety issues and regulatory science. The DSB is composed of representatives from two FDA Centers and eight other federal government agencies: the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS), Department of Defense (DOD), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), and Department of Veterans Affairs (VA). An important role of the DSB is to help FDA assess the impact of their safety decisions on the healthcare systems of its Federal Partners. The Board, with its broad representation from federal healthcare organizations, can provide valuable input and allows FDA to hear other perspectives on drug safety issues.
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FDA Medical Countermeasures Initiative (MCMi) Regulatory Science Steering 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 guidance to MCMi stakeholders.
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FDA Memorandum of Understanding with NHLBI [Docket No. FDA–2008–N–0043]
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Committee, Work group, Advisory group, or Task Force
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FDA
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NHLBI
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The group meets quarterly at alternate sites to discuss stem cell research, cell therapy research, and clinical trials related to these areas. Group members are invited to and attend CBER or NHLBI working groups and workshops on these topics.
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FDA Pediatric Advisory Committee
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Committee, Work group, Advisory group, or Task Force
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FDA
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NICHD
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This is a committee of ad hoc pediatric clinical pharmacologists and pediatricians.
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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 (FD) 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-NCI Monthly Meeting
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Meeting/ Workshop
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FDA
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NCI
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A monthly meeting to enhance communication between the two agencies, 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.
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FDA-NIH Tobacco Regulatory Science Workgroup
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Research Initiative
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FDA
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NIMH, CSR, FIC, NCI, NEI, NHGRI, NHLBI, NIAAA, NICHD, NIDA, NIDCD, NIDCR, NIEHS, NIGMS, NINDS, NINR, NLM, OD/DPCPSI/OBSSR
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The FDA-NIH Tobacco Regulatory Science Workgroup is comprised of NIH staff and staff from FDA Center for Tobacco Products. The purpose of the group is to leverage the research experience and capability of NIH to maximize the opportunity available in authorities given in the Family Smoking Prevention and Tobacco Control Act to reduce tobacco related morbidity and mortality. In 2014, the Tobacco Regulatory Science Program hosted a webinar for researchers on submitting comments to the FDA Docket. The webinar discussed the public comment/docket process and suggestions on submitting comments for public record on proposed FDA regulation. In addition, FDA recently published the proposed rule Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products (Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014).
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