The Food and Drug Administration announces its intention to accept and consider a single source application for award to the World Health Organization (WHO) for the Building Research Capacity in Global Tobacco Product Regulation Program. The purpose of the Program is to identify, support, develop, conduct, and coordinate research efforts relating to tobacco control laws and rules in foreign countries that will directly inform and support FDA's exercise of its authority to regulate the manufacture, distribution, marketing and sale of tobacco products in the United States. The Program will advance FDA's Center for Tobacco products' (CTP's) mission by utilizing the World Health Organization's (WHO) Member States' expertise and extensive international contacts in global tobacco control, as well as WHO's own programmatic expertise, to inform and support adequate manufacture, distribution and market regulations of tobacco products for the protection of public health in the United States. The Program will also provide a universal public benefit by creating opportunities for collaboration and research development globally, thereby resulting in better-informed and effective tobacco product regulation around the world, and increased knowledge in the public sphere regarding tobacco use and its harms globally.
Developers and innovators have many great ideas and products that could improve the U.S. health care system and make life better for patients and care providers. However, effecting actual change is extremely difficult due to the high barriers to entry in the health IT space. Once an innovative new product has been developed, it needs to be tested in real-life care settings. But providers can be hesitant to host this testing for a myriad of reasons-they may have had bad experiences in the past, be anxious about deploying new tools that may disrupt their workflows, or be wary of encountering more problems than the solution solves. Without this testing, it cannot be determined how well the product actually works, making it difficult for the developers to identify the changes that need to be made to the product to make it more effective. Furthermore, without evidence of the uses a product can provide it is that much harder to acquire the venture funding that can fuel further advancement and lead to successful entry in the marketplace.
The Market R&D Pilot Challenge is intended to help bridge this gap by bringing together health care organizations ("Hosts") and innovative companies ("Innovators") through pilot funding awards and facilitated matchmaking. The Challenge seeks to award pilot proposals in three different domains: Clinical environments (e.g., hospitals, ambulatory care, surgical centers), public health and community environments (community-based personnel such as public health departments, community health workers, mobile medical trucks, school- and jail-based clinics), and consumer health (e.g., self-insured employers, pharmacies, laboratories). Hosts and Innovators will submit joint pilot proposals, with the winners, as determined by an expert panel, proceeding to implement their pilots.
Nanomanufacturing is the production of useful nano-scale materials, structures, devices and systems in an economically viable manner. The NSF Nanomanufacturing Program supports fundamental research in novel methods and techniques for batch and continuous processes, top-down (addition/subtraction) and bottom-up (directed self-assembly) processes leading to the formation of complex heterogeneous nanosystems. The program supports basic research in nanostructure and process design principles, integration across length-scales, and system-level integration. The Program leverages advances in the understanding of nano-scale phenomena and processes (physical, chemical, electrical, thermal, mechanical and biological), nanomaterials discovery, novel nanostructure architectures, and new nanodevice and nanosystem concepts. It seeks to address quality, efficiency, scalability, reliability, safety and affordability issues that are relevant to manufacturing. To address these issues, the Program encourages research on processes and production systems based on computation, modeling and simulation, use of process metrology, sensing, monitoring, and control, and assessment of product (nanomaterial, nanostructure, nanodevice or nanosystem) quality and performance.The Program seeks to explore transformative approaches to nanomanufacturing, including but not limited to: micro-reactor and micro-fluidics enabled nanosynthesis, bio-inspired nanomanufacturing, manufacturing by nanomachines, additive nanomanufacturing, hierarchical nanostructure assembly, continuous high-rate nanofabrication such as roll-to-roll processing or massively-parallel large-area processing, and modular manufacturing platforms for nanosystems. The Program encourages the fabrication of nanomaterials by design, three-dimensional nanostructures, multi-layer nanodevices, and multi-material and multi-functional nanosystems. Also of interest is the manufacture of dynamic nanosystems such as nanomotors, nanorobots, and nanom
The goal of this funding opportunity announcement (FOA) is to support pilot testing of natural products (i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. Under this FOA, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. This FOA is not intended to support a randomized controlled trial (RCT) to test the efficacy of the natural product on clinical outcomes. Rather, the data collected should be used to fill gaps in scientific knowledge and provide the information necessary to develop a competitive full-scale clinical trial.
The purpose of this program is to support research activities that expand the knowledge base related to complex products and formulation development, analysis, and manufacturing control to advance risk-based quality assessment of new and generic drug products. We will also consider biological products relevant to CDER (e.g., monoclonal antibodies and therapeutic proteins) for this announcement.
The purpose of this Funding Opportunity Announcement (FOA) is to encourage biomedical, behavioral, and social science research that will inform the development and evaluation of regulations on tobacco product manufacturing, distribution, and marketing. Research projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The awards under this FOA will be administered by NIH using designated funds from the FDA CTP for tobacco regulatory science. Research results from this FOA are expected to generate findings and data that are directly relevant to inform the FDA's regulation of the manufacture, distribution, and marketing of tobacco Products to protect public health.
The purpose of this Funding Opportunity Announcement (FOA) is to encourage biomedical, behavioral, and social science research that will inform the development and evaluation of regulations on tobacco product manufacturing, distribution, and marketing. Research projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The awards under this FOA will be administered by NIH using designated funds from the FDA CTP for tobacco regulatory science. Research results from this FOA are expected to generate findings and data that are directly relevant to inform the FDA's regulation of the manufacture, distribution, and marketing of tobacco Products to protect public health.
The purpose of this Funding Opportunity Announcement (FOA) is to encourage biomedical, behavioral, and social science research that will inform the development and evaluation of regulations on tobacco product manufacturing, distribution, and marketing. Research projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The awards under this FOA will be administered by NIH using designated funds from the FDA CTP for tobacco regulatory science. Research results from this FOA are expected to generate findings and data that are directly relevant to inform the FDA's regulation of the manufacture, distribution, and marketing of tobacco Products to protect public health.
The purpose of this program is to provide funding to states to enhance/expand their treatment service systems to increase capacity and provide accessible, effective, comprehensive, coordinated care, and evidence-based medication assisted treatment (MAT) and recovery support services to individuals with opioid use disorders seeking or receiving MAT. As a result of this program, SAMHSA seeks to: 1) increase the number of individuals receiving MAT services with pharmacotherapies approved by the FDA for the treatment of opioid use disorders; 2) increase the number of individuals receiving integrated care; and 3) decrease illicit drug use at 6-months follow-up. For the purpose of this RFA, integrated care is defined as the organized delivery and/or coordination of medical, behavioral or social and recovery support services provided to individual patients in order to produce better overall health outcomes for people that may have multiple healthcare needs. MAT is defined as the use of FDA-approved opioid agonist medications (e.g., methadone, buprenorphine products including buprenorphine/naloxone combination formulations and buprenorphine mono-product formulations) for the maintenance treatment of opioid use disorder and opioid antagonist medication (e.g., naltrexone products including extended-release and oral formulations) to prevent relapse to opioid use. MAT includes screening, assessment (which includes determination of severity of opioid use disorder, including presence of physical dependence and appropriateness for MAT) and case management. MAT is to be provided in combination with comprehensive substance use disorder treatment, including but not limited to: counseling, behavioral therapies and when needed pharmacotherapy for co-occurring alcohol use disorder. MAT is to be provided in a clinically driven, person-centered and individualized setting. Priority will be given to states (listed in Appendix V) that have not only demonstrated a high rate of primary treatme
The purpose of this program is to support research activities that expand the knowledge base related to complex products and formulation development, analysis, and manufacturing control to advance risk-based quality assessment of new and generic drug products. We will also consider biological products relevant to CDER (e.g., monoclonal antibodies and therapeutic proteins) for this announcement.
The purpose of this Funding Opportunity Announcement (FOA) is to invite R01 applications to support biomedical and behavioral research that will provide scientific data to inform regulation of tobacco products to protect public health. Research Projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco products (CTP). The awards under this FOA will be administered by NIH using funds that have been made available through FDA CTP and the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Research results from this FOA are expected to generate findings and data that are directly relevant in informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.
The purpose of this Funding Opportunity Announcement (FOA) is to invite R01 applications to support biomedical and behavioral research that will provide scientific data to inform regulation of tobacco products to protect public health. Research Projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco products (CTP).
The awards under this FOA will be administered by NIH using funds that have been made available through FDA CTP and the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Research results from this FOA are expected to generate findings and data that are directly relevant in informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.
The Epilepsy Foundation has announced its eighth annual epilepsy "Shark Tank" competition for the most innovative ideas in epilepsy and seizure treatment and care.
Examples of novel ideas include a system to detect seizures with the capacity to provide early warning to the patient or family; a treatment that stops a seizure from progressing; a system that helps patients manage their daily treatment; a device that prevents physical injury that patients may experience when in seizure; or an entirely new product concept with the promise to dramatically improve the lives of people with epilepsy.
Selected finalists will receive international recognition and compete for grants totaling $200,000 to support the development and commercialization of their new product, technology, or therapeutic concept.
As many as six finalists will be selected to present at the 2019 Anti-Epileptic Drug & Device Trials, May 22-24, 2019, in Miami. Each presenter will have five minutes to present the concept, followed by five minutes of questioning. The event will feature live voting among audience members and a panel of judges (Sharks) representative of industry, advocacy, investors, and the research and medical communities. The project (or projects) deemed to be the most innovative will be announced at the conclusion of the competition.
The PRMRP Technology/Therapeutic Development Award (TTDA) is a product-driven award mechanism intended to provide support for the translation of promising preclinical findings into products for clinical applications, including prevention, detection, diagnosis, treatment, or quality of life, in at least one of the Congressionally directed FY18 PRMRP Topic Areas. products in development should be responsive to the healthcare needs of military Service members, Veterans, and/or beneficiaries.
The purpose of this Funding Opportunity Announcement (FOA) is to invite R01 applications to support biomedical and behavioral research that will provide scientific data to inform regulation of tobacco products to protect public health. Research Projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco products (CTP). The awards under this FOA will be administered by NIH using funds that have been made available through FDA CTP and the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Research results from this FOA are expected to generate findings and data that are directly relevant in informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.
The purpose of this Funding Opportunity Announcement (FOA) is to invite R03 applications to support biomedical and behavioral research that will provide scientific data to inform regulation of tobacco products to protect public health. Research Projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco products (CTP). The awards under this FOA will be administered by NIH using funds that have been made available through FDA CTP and the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Research results from this FOA are expected to generate findings and data that are directly relevant in informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.
The intended goal of this FOA is to facilitate the development, production, and distribution of pediatric medical devices. Although the FOA is issued by the FDA's Office of Orphan Products Development, the grant application is intended to encompass devices for all pediatric diseases and conditions, not just those that are rare. Applicants will request funding to serve as a nonprofit consortium to provide expert advising and support services to innovators of pediatric medical devices. The advising and services will focus on the total product life cycle for medical devices from concept, through pre-market development, to commercialization, and replacement by subsequent generation of devices.
The purpose of this Funding Opportunity Announcement (FOA) is to invite R01 applications to support biomedical and behavioral research that will provide scientific data to inform regulation of tobacco products to protect public health. Research Projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco products (CTP). The awards under this FOA will be administered by NIH using funds that have been made available through FDA CTP and the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Research results from this FOA are expected to generate findings and data that are directly relevant in informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.
The CRRP seeks to enhance medical capabilities at the point of greatest need in order to save the most lives in future combat scenarios, which may be complicated by limited resources, austere conditions, and/or mass casualty events. The intent of the FY19 CRRP RDTRA is to support research that will accelerate the movement of promising ideas into clinical applications, including healthcare products, technologies, and/or practice guidelines. Applicants may leverage existing resources in translational research to address high-impact research ideas or unmet needs in delivering lifesaving care to the Warfighter during prolonged and en route care in austere and combat environments. Research of interest may include knowledge products, "knowledge resulting from research with the potential to improve individual or public health,"2 and solutions that can accelerate the introduction of military-relevant health products or technologies into clinical and/or operational use. For this award mechanism, the definition of "leveraging" is as follows: An investigator basing a research project on existing resources in order to amplify potential gains in knowledge or accelerate technical maturity.
The purpose of this Funding Opportunity Announcement (FOA) is to invite research project applications to support biomedical and behavioral research that will provide scientific data to inform regulation of tobacco products to protect public health. Research Projects must address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco products (CTP). The awards under this FOA will be administered by NIH using funds that have been made available through FDA CTP and the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31). Research results from this FOA are expected to generate findings and data that are directly relevant in informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.
