The purpose of this study is to: 1) collect information on practice patterns in special populations to assess possible barriers to generic substitution ; 2) compare clinical practice (e.g., drug product manipulation prior to administration, co-administration with another food or drug) with labeled drug administration information in the assessed populations to identify factors that raise issues for safety and effectiveness with generic substitution; and 3) analyze the impact of product-level, patient-level, and provider-level factors on generic drug substitution. The outcome of this study will help identify research needs, support FDA's regulatory science efforts to monitor and ensure successful generic substitution, and provide evidence to assure the public on generic drug safety and effectiveness.
The overall goal of The Step Up for SUD initiative is to advance fundamental discoveries into medicines to treat substance use disorders (SUD) for the benefit of society. The purpose of this funding opportunity is to enhance and accelerate research on drug targets for SUD aiming to expand the range of targets and mechanisms in development for SUD therapies. The initiative will provide both funding and the in-kind access to biomedical product development experts. It will be administered as a unique, short-term and nimble funding opportunity to support the confirmatory research in robust drug target validation/invalidation to allow for early decision to either proceed to a next step or stop the projects. At this point, only research projects on potential drug/biologic therapeutics, not diagnostics or devices, will be supported.
The purpose of this funding opportunity is to support the research and development necessary to advance non-invasive (e.g., quantitative tomography-based) technologies, including the development of apparatus, methods, study designs, and methods of data analysis, to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis and dermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products.
The purpose of this Funding Opportunity Announcement (FOA) is to invite cooperative agreement applications for research that advances promising compounds through the drug development pipeline for the treatment of Alcohol Use Disorder (AUD).
NIAAA is seeking applications for medications development research projects from both for-profit and not-for-profit entities, including academic institutions, pharmaceutical and biotechnology companies, private and public foundations, small businesses not eligible for the SBIR/STTR program and single entities able to demonstrate significant resource commitment to the proposed project. A resource commitment from a single entity could, for example, consist of salary support for key personnel or production and formulation of clinical trial material.
The aim of this FOA is to move candidate compounds through Investigational New Drug (IND) requirements, Phase 1 human safety, tolerability, and dosing studies, and Phase 2 human laboratory and proof-of-concept trials. Within these phases of drug development, each proposed project should have a defined entry and exit point. Finally, this FOA will support animal studies to prove efficacy if the candidate compound is patentable and has a plausible path to commercialization. Applicants are strongly encouraged to contact the NIAAA Division of Medications Development Staff prior to submitting to this FOA.
The goal of this program is to support the advancement of regulatory science to facilitate the implementation and the assessment of continuous manufacturing and similar innovative monitoring and control techniques in the pharmaceutical sector. This will be accomplished by making awards to institutions of higher education and nonprofit organizations for the purpose of studying and recommending improvements to the process of continuous manufacturing of drugs and biological products (e.g., monoclonal antibodies and therapeutic enzymes). Examples of activities could include the development or modification of a novel manufacturing process (e.g., design, scale-up, and/or commercial scale), control method, and/or testing technology. Awards made under this FOA may be funded in part by appropriations received under the 21st Century Cures Act, section 3016.
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), Division of Cardiovascular and Renal Products (DCRP) is announcing its intent to accept and consider applications for the award of a grant to support the Heart Failure Collaboratory
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.
A. Purpose and Priorities The National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program will award grants that increase the understanding and adoption of established food safety standards, guidance, and protocols. Grants awarded through this program will be carried out in a manner that facilitates the integration of food safety standards and guidance with a variety of agricultural production systems, including conventional, sustainable, organic, and conservation and environmental practices carried out by the eligible entities. The assistance provided by these programs, to the extent practicable, shall be coordinated with and delivered in cooperation with similar services or assistance by other federal agencies or programs serving those eligible entities. The U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture's National Institute of Food and Agriculture (NIFA) have joined in a collaborative partnership to administer and manage the National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program. This program is designed to develop a comprehensive food safety training, education and technical assistance program for those affected by the FDA Food Safety Modernization Act (FSMA). Specifically, this program will address the needs of owners and operators of small and medium-sized farms, beginning farmers, socially disadvantaged farmers, small processors, and small fresh fruit and vegetable merchant wholesalers. The joint program will award competitive grant funds that enable awardees to establish a National Coordination Center (NCC) for Food Safety Training, Education, Extension, Outreach, and Technical Assistance and Regional Centers (RC) for Food Safety Training, Education, Extension, Outreach, and Technical Assistance across the country for food safety training, education, and technical assistance. Project Teams for the RCs will reach out into local communities to work wi
The Therapeutic Development Award supports research ranging from validation of therapeutic leads through U.S. Food and Drug Administration (FDA) Investigational New Drug (IND)- enabling studies. The proposed studies are expected to be empirical in nature and product- driven. Applicants with limited ALS experience are strongly encouraged to collaborate with those having substantial expertise in ALS research and/or ALS model systems. Examples of activities that will be supported by this award include:
Confirmation of candidate therapeutics obtained from screening or by other means, including optimization of potency and pharmacological properties and testing of derivatives and sister compounds
Validation of early pilot studies, including the use of multiple ALS model systems and/or replicating preliminary data with more time points or additional doses
Studies on formulation and stability leading to Good Manufacturing Practice (GMP) production methods
IND-enabling studies, to include compound characterization, absorption, distribution, metabolism, and excretion (ADME) studies, and dose/response and toxicology studies in relevant model system
The Therapeutic Development Award supports research ranging from validation of therapeutic leads to U.S. Food and Drug Administration (FDA) Investigational New Drug (IND)-enabling studies. The proposed studies are expected to be empirical in nature and product-driven. Applicants with limited ALS experience are strongly encouraged to collaborate with those having substantial expertise in ALS research and/or ALS model systems. Examples of activities that will be supported by this award include: * Confirmation of candidate therapeutics obtained from screening or by other means, including optimization of potency and pharmacological properties and testing of derivatives and sister compounds * Validation of early pilot studies, including the use of multiple ALS model systems and/or replicating preliminary data with more time points or additional doses * Studies on formulation and stability leading to Good Manufacturing Practice (GMP) production methods * IND-enabling studies, to include compound characterization, absorption, distribution, metabolism, and excretion (ADME) studies, and dose/response and toxicology studies in relevant model systems Validation of treatment approaches in appropriately powered and controlled studies using biological correlates of disease activity and progression in pre-existing, de-identified human specimens from well-characterized patient cohorts is encouraged. Examples of acceptable cohorts for study include controlled clinical trials, observational studies, and registries (e.g., Centers for Disease Control and Prevention National ALS Registry and/or Biorepository; https://wwwn.cdc.gov/als/).
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 objective of this Funding Opportunity Announcement (FOA) is to support the development of new and innovative multipurpose prevention technologies (MPT) with rheological/biophysical properties and product user perceptions compatible with current long-acting reversible contraceptive (LARC) strategies (look, feel, effectiveness, safety and duration of action) for the dual purpose of preventing pregnancy and HIV infection in women. MPTs proposed for development must be dual indication and prevent pregnancy and HIV infection and have drug delivery systems (DDS) capable with sustained/extended release of both drugs. MPTs proposed for development must use a licensed contraceptive. This FOA requires an industry partner, milestones linked to Go/No Go decisions and year 5 funding requires submission of a pre-IND application to the FDA.
The objective of this Funding Opportunity Announcement (FOA) is to support the development of new and innovative multipurpose prevention technologies (MPT) with rheological/biophysical properties and product user perceptions compatible with current long-acting reversible contraceptive (LARC) strategies (look, feel, effectiveness, safety and duration of action) for the dual purpose of preventing pregnancy and HIV infection in women. MPTs proposed for development must be dual indication and prevent pregnancy and HIV infection and have drug delivery systems (DDS) capable with sustained/extended release of both drugs. MPTs proposed for development must use a licensed contraceptive. This FOA requires an industry partner, milestones linked to Go/No Go decisions and year 5 funding requires submission of a pre-IND application to the FDA.
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 accelerate development of safe and effective long-acting drug delivery systems (LA-DDS) for improved, simplified treatment of HIV-1 in children. This FOA invites applicants engaged in the development of existing LA-DDS platforms at early product development stages to perform specific preclinical activities that enable product optimization and accelerated translation to HIV-1 infected children. Collaborative research partnerships with industry are required.
The purpose of this Funding Opportunity Announcement (FOA) is to accelerate development of safe and effective long-acting drug delivery systems (LA-DDS) for improved, simplified treatment of HIV-1 in children. This FOA invites applicants engaged in the development of existing LA-DDS platforms at early product development stages to perform specific preclinical activities that enable product optimization and accelerated translation to HIV-1 infected children. Collaborative research partnerships with industry are required.
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 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.
