$1,000,000

Due: 2023-02-28

Summary: Orally Inhaled Drug Products (OIDPs) are complex drug-device combination products. To establish bioequivalence for locally acting OIDPs, FDA is currently using a weight-of-evidence approach which generally includes a combination of in vitro BE studies; in vivo pharmacokinetic (PK) studies and comparative clinical endpoint (CCEP) or pharmacodynamic… Read More

$450,000

Due: 2023-03-15

Summary: The FDA guidance, Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (Aug 2021), provides recommendations for demonstrating the bioequivalence of additional strengths of a proposed modified release drug product. The recommendations involve evidence to demonstrate the same drug release mechanism and similar dissolution… Read More

$1,200,000

Due: 2023-03-22

Summary: The purpose of this research is to systematically evaluate the diastereomeric composition of LEQVIO (Inclisiran), an FDA-approved, N-acetylgalactosamine (GalNAc)-conjugated siRNA drug, and to understand the biological/pharmacological activity of each diastereomer in LEQVIO through stereochemically-controlled synthesis and biological activity assessment… Read More

$500,000

Due: 2023-02-15

Summary: The purpose of this funding opportunity is to develop a workflow for designing and performing a reliable virtual bioequivalence study by leveraging a physiologically-based pharmacokinetic (PBPK) model, validated for its intended purpose, to detect formulation differences between the reference standard product and a prospective generic drug product.… Read More

$4,500,000

Due: 2023-03-13

Summary: The primary objective of this effort is to provide supporting research, identify key issues, and convene appropriate subject matter experts to help inform major regulatory science initiatives related to FDA commitments under the 2022 reauthorization of the Prescription Drug User Fee Act (PDUFA VII) and Biosimilars User Fee Act (BsUFA III). Read More

$105,000

Due: 2023-02-14

Summary: FDA is announcing its intention to accept and consider a renewal application for a cooperative agreement, with the availability of approximately $105,000 in total fiscal year (FY) 2023 funds, in support of coordination of Federal and State actions to assure radiation protection of the American public. The recipient will also plan and facilitate an… Read More

Funding Varies

Due: 2023-01-16

Summary: The purpose of this funding opportunity announcement (FOA) is to fund COVID research that will strengthen and advance research in minority health and healthy equity, increase understanding of health disparities, and provide future direction for research that will contribute to regulatory decision making.The FDA Office of Minority Health and Health… Read More

$400,000

Due: 2023-01-17

Summary: The following organization is eligible to apply:The World Health Organization (WHO)As FDA seeks to proactively work with other countries and identify research and evaluation opportunities that will impact FDA’s ability to successfully implement the Tobacco Control Act, further collaboration with WHO is anticipated. With the financial support… Read More

Funding Varies

Due: Applications Ongoing

Summary: The purpose of this funding opportunity announcement (FOA) is to fund COVID research that will strengthen and advance research in minority health and healthy equity, increase understanding of health disparities, and provide future direction for research that will contribute to regulatory decision making.OMHHE is interested in research proposals that… Read More

Funding Varies

Due: Applications Ongoing

Summary: The purpose of the funding opportunity is to expand and advance FDA's Office of Minority Health and Health Equity (OMHHE) work with stakeholders and partners for education, outreach, and public awareness activities on the use of and potential risks from skin lightening products (e.g., hydroquinone).Applicants will propose innovative and community-based… Read More

Funding Varies

Due: Applications Ongoing

Summary: The purpose of this funding opportunity announcement (FOA) is to fund collaborative research projects to enhance EQUITY in clinical trials by supporting efforts to advance diversity in clinical trials, EQUITABLE data efforts by increasing data available on diverse groups including, but not limited to, ethnicity, race, age, disability and geography,… Read More

Funding Varies

Due: Applications Ongoing

Summary: The goal of this FOA is to support a convener for FDA OMHHE's Racial & Ethnic minority Acceleration Consortium for Health Equity (REACH). REACH, supported through a separate FOA, will consist of 5-8 multi-project cooperative agreement (U01) awardees that will strengthen and advance minority health and health equity regulatory needs by supporting… Read More

Funding Varies

Due: Applications Ongoing

Summary: This Funding Opportunity Announcement (FOA) is for FDA OMHHE's Racial & Ethnic minority Acceleration Consortium for Health equity (REACH) which solicits applications from diverse institutions, to participate in a consortia to strengthen and advance minority health and health equity. The consortium will consist of 5-8 multi-project cooperative… Read More

$5,000,000

Due: 2022-12-22

Summary: The FDA hosts the Centers of Excellence in Regulatory Science and Innovation (CERSI) Program to foster robust and innovative approaches to advance regulatory science, and the goal is for the CERSIs to advance regulatory science individually and synergistically, under the CERSI Program led by the Office of Regulatory Science and Innovation (ORSI), through… Read More

$400,000

Due: Applications Ongoing

Summary: This project will continue a 10 year program that has sought to provide collaborative training, hands-on training and education for government, academic, and industry researchers. As such, the outcomes of the project are not limited to FDA (or interagency partners), but extend to both the research community (in order to better operate in high consequence… Read More

Funding Varies

Due: Applications Ongoing

Summary: The recent marked increase in the volume of marketing applications submitted to FDA for oncology indications that are primarily supported by pivotal trials in only one country or in countries limited to one or two geo-political regions now makes it imperative for the FDA OCE and oncology stakeholders to discuss the ethics and considerations around… Read More

Funding Varies

Due: Applications Ongoing

Summary: OCE is interested to understand factors that affect the safety and treatment response in oncology therapeutic development for demographic subgroups that have been historically underrepresented in oncology trials (e.g., racial/ethnic minorities, sexual and gender minorities, older adults). Risk factors, underlying differences in the disease biology,… Read More

$8,250,000

Due: Applications Ongoing

Summary: The purpose of the NOFO is to facilitate long-term improvements and innovation to the national integrated food safety system by unifying and coordinating federal/state/local human and animal food (HAF) emergency response efforts including:1) Strengthening the link among epidemiology, lab, and environmental health/regulatory components;2) Improving… Read More

Funding Varies

Due: Applications Ongoing

Summary: The purpose of the NOFO is to advance efforts for a nationally integrated food safety system (IFSS) by supporting Manufactured Food Regulatory Program Standards (MFRPS), dietary supplement safety and oversight programs, improved state compliance and enforcement infrastructure, and state Food Protection Task Force (FPTF) programs. The MFRPS are intended… Read More

$5,000,000

Due: 2023-02-27

Summary: The purpose of this NOFO is to encourage new approaches to support therapeutic development in ultra-rare pediatric and adult cancers, including molecularly-defined subsets of more common cancers. Read More

Funding Varies

Due: Applications Ongoing

Summary: The purpose of this program is to enable harmonized approaches, standards and guidelines in order to strengthen innovation, development, regulation and availability of medical devices that meet quality and safety requirements in the African continent. These efforts are critical to ensure consistent and aligned practices for the regulatory oversight… Read More

Funding Varies

Due: Applications Ongoing

Summary: The purpose of this program is to support data driven and science based regulatory practices and approaches in order to build a global consensus on criteria for an optimal good manufacturing practice(GMP) inspection, establish core competencies for inspectors or investigators, and develop global regulatory capacity to plan and prioritize inspections… Read More

Funding Varies

Due: Applications Ongoing

Summary: To advance food safety best practices and adoption of the Food Safety Modernization Act (FSMA) requirements for food products exported to the United States from Latin America. Read More

Funding Varies

Due: Applications Ongoing

Summary: The purpose of this funding opportunity announcement (FOA) is to fund clinical trials of products evaluating safety and/or efficacy in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects… Read More

Funding Varies

Due: 2023-05-03

Summary: The purpose of this funding opportunity announcement (FOA) is to support research to continue the development of drug development tools that have an accepted Letter of Intent (LOI) within a drug development tool qualification program within either CBER or CDER.The grants will be used to further the development of tools that, once qualified, will be… Read More

Funding Varies

Due: Applications Ongoing

Summary: The BsUFA program requires substantial programmatic involvement to ensure the projects are applicable across more than one product or product class and the intended outcomes of these studies must be translatable to regulatory expectations. By using the cooperative agreement mechanism, the program will be able to have more interactions with the projects;… Read More

$1,800,000

Due: 2024-02-09

Summary: The purpose of this Funding Opportunity Announcement (FOA) is to solicit applications from institutions/ organizations for inclusion into FDA's Veterinary Laboratory Investigation and Response Network Cooperative Agreement Program for Veterinary Diagnostic laboratories. This cooperative agreement program is intended to build domestic laboratory… Read More

$1,600,000

Due: Applications Ongoing

Summary: The purpose of this funding opportunity announcement (FOA) is to support studies that advance medical product development through the characterization of the natural history of rare diseases/conditions with unmet needs. Through the support of efficient and innovative natural history studies, FDA expects to address critical knowledge gaps, to remove… Read More

Funding Varies

Due: Applications Ongoing

Summary: Data concepts (not just the information but the underlying definition of its meaning) between many different sources of RWD (EHRs, Claims, digital health technologies, etc.) as well as those used in clinical research and regulatory submission are almost always similar but not identical. This fact makes mapping and transforming data between RWD and… Read More

Funding Varies

Due: Applications Ongoing

Summary: The objective of this project is to develop a nasal PBPK model that includes at least one pathway for nose-to-brain drug delivery and links with a full body PBPK model that includes, at least, a brain compartment. It is expected that the model will rely on experimental data as much as possible, where experimental studies may need to be included in… Read More

Funding Varies

Due: Applications Ongoing

Summary: The objective of this work is to support the research to develop in vitro test methods for TDS that can correlate with and be predictive of TDS adhesion performance in vivo. The expected outcome of this research is that novel in vitro test methods will be developed which subject the TDS to biorelevant conditions that make it possible to establish in… Read More

Funding Varies

Due: 2024-02-13

Summary: The purpose of this funding opportunity announcement (FOA) is to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps,… Read More

$500,000

Due: 2024-02-02

Summary: This Notice of Funding Opportunity (NOFO) is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions or organizations that propose to develop or support the development of designated new animal drugs intended for minor uses in major species or for… Read More

Funding Varies

Due: Applications Ongoing

Summary: The purpose of the NOFO is to expand and advance FDA's Office of Minority Health and Health Equity (OMHHE) work with stakeholders and partners for education, outreach, and public awareness activities on the dangers of skin lightening products containing hydroquinone and mercury.Applicants will propose innovative and community based strategies… Read More

Funding Varies

Due: Applications Ongoing

Summary: OMHHE’s Enhance Equity Initiative will support research projects that enhance EQUITY in clinical trials by supporting efforts to advance clinical trial diversity, EQUITABLE data efforts by increasing data available on diverse groups including, but not limited to, ethnicity, race, age, disability and geography, and EQUITY of voices by amplifying… Read More

$1,000,000

Due: Applications Ongoing

Summary: ACTTION/PASI public-private partnership (PPP) is a multi-year, multi-phase initiative that is aligned with the FDA's Critical Path Initiative. This ppp has been designed to streamline the discovery and development process for new analgesic, anesthetic, addiction, and peripheral neuropathy medications. In addition, this PPP is established to address… Read More

$5,000,000

Due: Applications Ongoing

Summary: The purpose of this funding opportunity announcement (FOA) is to fund COVID research that will strengthen and advance research in minority health and healthy equity, increase understanding of health disparities, and provide future direction for research that will contribute to regulatory decision making.OMHHE is interested in research proposals that… Read More

Funding Varies

Due: Applications Ongoing

Summary: The proposed cooperative agreement is a renewal of the existing CAP supporting key stakeholders in retail food safety to coordinate and advance retail food protection in the United States. The intended outcome of this NOFO is to collaboratively advance retail food safety initiatives to reduce food-borne illness. This cooperative agreement is intended… Read More

$35,000,000

Due: 2023-03-01

Summary: The overall purpose of this funding is to advance efforts for a national integrated food safety system (IFSS) by supporting state and territory Produce Safety Programs to enhance produce safety and achieve high rates of compliance with the FDA’s Produce Safety Rule by way of regulatory programs focused on quality and national consistency; education… Read More

$4,500,000

Due: 2023-04-14

Summary: The purpose of this Funding Opportunity Announcement (FOA) is to support enhanced human and animal food safety by strengthening the capacity, collaboration, and integration of food-safety laboratories and networks, thereby facilitating an effective and coordinated response to future human and animal food safety issues. The current FOA solicits applications… Read More

$8,000,000

Due: Applications Ongoing

Summary: This research will advance pathogen reduction technologies by developing innovative technologies and by bridging the gaps between discoveries in academia or industry and ultimately implementation by blood establishments. Results of this comprehensive research will support integrated pathogen reduction technologies (PRT) for the blood safety. The overall… Read More

Funding Varies

Due: Applications Ongoing

Summary: The purpose of this grant is to provide funding for NEST ( National Evaluation System for health Technology) in hiring personnel with expertise regarding RWE ( Real Word Evidence). Real-world evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWE can be generated… Read More

Funding Varies

Due: Applications Ongoing

Summary: To identify, adapt, and/or develop, data standards and/or applications of data standards to improve the timeline of pharmaceutical development, application submission, regulatory review, and/or post-martketing activities including safety surveillance. Read More

$1,000,000

Due: Applications Ongoing

Summary: The purpose of this SAMHSA program is to expand access to naloxone and other Food and Drug Administration (FDA)-approved overdose reversal medications for emergency treatment of known or suspected opioid overdose. The recipients will partner with other prescribers at the community level to implement trainings on policies, procedures, and models of… Read More

Funding Varies

Due: 2023-04-05

Summary: This Funding Opportunity Announcement (FOA), issued by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), invites eligible United States small businesses to submit Small Business Innovation Research (SBIR) grant applications. United States small businesses that… Read More

$1,000,000

Due: 2023-03-08

Summary: The purpose of this Funding Opportunity Announcement (FOA) is to invite R21 applications to stimulate exploratory research relevant to the mission of the Food and Drug Administration (FDA) - Center for Tobacco Products (CTP) using existing (publicly available) biospecimens currently stored in repositories in the United States. This will include, but… Read More

$750,000

Due: Applications Ongoing

Summary: The National Science Foundation (NSF), through the Directoratefor Engineering, the Directorate of Computer and Information Science and Engineering Division of Computer and Network Systems, and the Directorate for Mathematical and Physical Sciences Division of Materials Research, along with the U.S. Food and Drug Administration (FDA), through its Center… Read More

$5,500,000

Due: 2023-01-19

Summary: The purpose of the BRAG program Assistance Listing 10.219 is to support the generation of new information that will assist Federal regulatory agencies [USDA’s – Animal and Plant Health Inspection Service - Biotechnology Regulatory Services (APHIS-BRS), Environmental Protection Agency (EPA), and Department of Health and Human Services (DHHS)… Read More

Funding Varies

Due: 2023-02-14

Summary: 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… Read More

$1,000,000

Due: 2023-03-08

Summary: The purpose of this Funding Opportunity Announcement (FOA) is to invite R21 applications proposing the innovative analysis of existing (publicly available) nationally representative U.S. cross-sectional and longitudinal data, to investigate novel scientific ideas and/or to generate new models, systems, tools, methods, or technologies that have the… Read More

Funding Varies

Due: 2025-01-07

Summary: Reissue of PAR-18-942. The purpose of this funding opportunity announcement (FOA) is to encourage applications seeking to develop the next generation of brain stimulation devices for treating mental health disorders. Applications are sought that will either 1) develop novel brain stimulation devices or 2) significantly enhance, by means of hardware/software… Read More

Funding Varies

Due: 2025-01-07

Summary: Reissue of PAR-18-941. The purpose of this funding opportunity announcement (FOA) is to encourage applications seeking to develop the next generation of brain stimulation devices for treating mental health disorders. Applications are sought that will either 1) develop novel brain stimulation devices or 2) significantly enhance, by means of hardware/software… Read More

$4,000,000

Due: 2024-02-20

Summary: The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from Small Business Concerns (SBCs) to pursue translational activities and small clinical studies to advance the development of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. The translational device activities,… Read More

Funding Varies

Due: 2023-04-05

Summary: The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from small business concerns (SBCs) to the newly re-authorized Commercialization Readiness Pilot (CRP) program. The FOA aims to facilitate the transition of previously funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing… Read More

Funding Varies

Due: 2025-03-12

Summary: The purpose of the Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01) is to provide support and protected time (three, four, or five years) for an intensive, supervised career development experience in biomedical, behavioral, and social science research that will inform the development and evaluation of regulations… Read More

Funding Varies

Due: 2025-03-12

Summary: The purpose of the Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01) is to provide support and protected time (three, four, or five years) for an intensive, supervised career development experience in biomedical, behavioral, and social science research that will inform the development and evaluation of regulations… Read More

Funding Varies

Due: Applications Ongoing

Summary: PurposeThe COVID-19 Coverage Assistance Fund will provide claims reimbursement at the national Medicare rate for eligible healthcare providers administering authorized COVID-19 vaccines to underinsured individuals.To participate, providers must attest to the following at registration: Have submitted a vaccine administration claim to the patient's healthcare… Read More

Funding Varies

Due: 2024-12-04

Summary: This Funding Opportunity Announcement (FOA) supports Small Business Technology Transfer (STTR) applications from small business concerns (SBCs) that propose the development of therapeutic agents for the treatment of alcohol use disorder (AUD) and/or alcohol associated organ damage (AAOD). As a starting point, eligible applicants must identify a therapeutic… Read More

Funding Varies

Due: 2024-12-04

Summary: This Funding Opportunity Announcement (FOA) supports Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that propose the development of therapeutic agents for the treatment of alcohol use disorder (AUD) and/or alcohol associated organ damage (AAOD). As a starting point, eligible applicants must identify a therapeutic… Read More