Food and Drug Administration (FDA) Funding This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

PHS 2022-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
Funding Opportunity PA-22-176 from the NIH Guide for Grants and Contracts. 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 have the research capabilities and technological expertise to contribute to the R and D mission(s) of the NIH, CDC, and FDA awarding components identified in this FOA are encouraged to submit SBIR grant...
Source: NIH Funding Opportunities (Notices, PA, RFA) - June 2, 2022 Category: Research Source Type: funding

Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required)
Funding Opportunity RFA-NS-22-071 from the NIH Guide for Grants and Contracts. The National Institute of Neurological Disorders and Stroke (NINDS) and the Office of the Director, National Institutes of Health (OD), intend to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for the conduct of scientific research utilizing data from expanded access (EA) to investigational drugs or biological products. These applications will target intermediate size populations of patients living with amyotrophic lateral sclerosis (ALS) who are not otherwise eligible for clinical tria...
Source: NIH Funding Opportunities (Notices, PA, RFA) - May 12, 2022 Category: Research Source Type: funding

Reducing Administrative Burden in Laboratory Animal Research: What Have We Done Recently and What ’s Coming…
Pat Brown, Director, NIH Office of Laboratory Animal Welfare The 21st Century Cures Act called for NIH to collaborate with the U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) to reduce administrative burdens associated with laboratory animal research programs, while maintaining high standards of animal welfare as well as the integrity and credibility of the research. We jointly released a final report in 2019 outlining steps to accomplish this goal, and have since worked together to implement many of the recommendations. We wanted to take this opportunity today to share some of NIH’s progress...
Source: NIH Extramural Nexus - April 20, 2022 Category: Research Authors: Mike Lauer Tags: blog Open Mike Administrative Burden Animal Welfare RFI Source Type: funding

IND-enabling Studies of Somatic Genome Editing Therapeutic Leads (U19, Clinical Trial Not allowed)
Funding Opportunity RFA-RM-22-015 from the NIH Guide for Grants and Contracts. This funding opportunity announcement (FOA) is part of a suite of FOAs of the NIH Common Fund Somatic Cell Genome Editing (SCGE) Phase II Program. The goal of this U19 FOA is to support team-based research Projects to accelerate further optimization and development of genome editing-based therapeutic leads towards IND-enabling studies and an IND (Investigational New Drug) application submission to the U.S. Food and Drug Administration (FDA). The proposed leads should demonstrate strong biological rationale and in vitro and/or in vivo proof of...
Source: NIH Funding Opportunities (Notices, PA, RFA) - April 11, 2022 Category: Research Source Type: funding

Center for Coordination of Analysis, Science, Enhancement, and Logistics (CASEL) in Tobacco Regulatory Science (U54 Clinical Trial Not Allowed)
Funding Opportunity RFA-OD-22-003 from the NIH Guide for Grants and Contracts. The purpose of this funding opportunity announcement (FOA) is to solicit applications for a Center for Coordination of Analysis, Science, Enhancement, and Logistics (CASEL) in Tobacco Regulatory Science. The overall objective of CASEL is scientific coordination and logistics and operations management of research projects and programs that can inform the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) in its tobacco product regulatory activities. Through leadership, coordination, and facilitation of communication and colla...
Source: NIH Funding Opportunities (Notices, PA, RFA) - March 7, 2022 Category: Research Source Type: funding

Tobacco Centers of Regulatory Science (TCORS) for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (U54 Clinical Trial Optional)
Funding Opportunity RFA-OD-22-004 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to invite applications for Tobacco Centers of Regulatory Science (TCORS) 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 Objectives related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP). (Source: NIH Funding Opportunities (Notices, PA, RFA))
Source: NIH Funding Opportunities (Notices, PA, RFA) - March 7, 2022 Category: Research Source Type: funding

Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use disorder and Alcohol-Associated Organ Damage (U43/U44 Clinical Trial Optional)
Funding Opportunity PAR-22-102 from the NIH Guide for Grants and Contracts. 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 candidate with a robust body of background data in the basic science and early discovery phases to be ready for transition to the preclinical and clinical phases of development. Data may inclu...
Source: NIH Funding Opportunities (Notices, PA, RFA) - January 21, 2022 Category: Research Source Type: funding

Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use disorder and Alcohol-Associated Organ Damage (UT1/UT2 Clinical Trial Optional)
Funding Opportunity PAR-22-103 from the NIH Guide for Grants and Contracts. 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 candidate with a robust body of background data in the basic science and early discovery phases to be ready for transition to the preclinical and clinical phases of development. Data may inclu...
Source: NIH Funding Opportunities (Notices, PA, RFA) - January 21, 2022 Category: Research Source Type: funding

Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R01 Clinical Trial Not Allowed)
Funding Opportunity PAR-22-039 from the NIH Guide for Grants and Contracts. 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 improvements, the effectiveness of brain stimulation devices that are currently U.S. Food and Drug Administration (FDA)-approved or cleared. Novel devices should move beyond existing electric...
Source: NIH Funding Opportunities (Notices, PA, RFA) - October 12, 2021 Category: Research Source Type: funding

Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R21 Clinical Trial Not Allowed)
Funding Opportunity PAR-22-038 from the NIH Guide for Grants and Contracts. 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 improvements, the effectiveness of brain stimulation devices that are currently U.S. Food and Drug Administration (FDA)-approved or cleared. Novel devices should move beyond existing electric...
Source: NIH Funding Opportunities (Notices, PA, RFA) - October 12, 2021 Category: Research Source Type: funding

Innovation Award: COVID-19 and Health Equity (U01) Clinical Trials Optional
Funding for innovative projects that will strengthen and advance COVID-19 health equity research. One area of interest includes proposals that support the evaluation of outcomes by demographic data including, but not limited to, ethnicity, race, age, disability, and geography. Geographic coverage: Nationwide -- Food and Drug Administration, U.S. Department of Health and Human Services (Source: Funding opportunities via the Rural Health Information Hub)
Source: Funding opportunities via the Rural Health Information Hub - September 27, 2021 Category: American Health Source Type: funding

Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)
Funding Opportunity RFA-HL-22-014 from the NIH Guide for Grants and Contracts. The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seeks highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. App...
Source: NIH Funding Opportunities (Notices, PA, RFA) - July 13, 2021 Category: Research Source Type: funding

PHS 2021-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
Funding Opportunity PA-21-259 from the NIH Guide for Grants and Contracts. 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 have the research capabilities and technological expertise to contribute to the R and D mission(s) of the NIH, CDC, and FDA awarding components identified in this FOA are encouraged to submit SBIR grant...
Source: NIH Funding Opportunities (Notices, PA, RFA) - July 8, 2021 Category: Research Source Type: funding

Translational Neural Devices (U44 Clinical Trial Optional)
Funding Opportunity RFA-NS-21-022 from the NIH Guide for Grants and Contracts. 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, including translational bench and animal studies, are expected to lead to submission of an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) or Institutional Re...
Source: NIH Funding Opportunities (Notices, PA, RFA) - April 28, 2021 Category: Research Source Type: funding

The NIH SABV Policy: E-learning Opportunities and a Symposium Provide Guidance and Inspiration
Interest in sex and gender in research—and resources to help investigators—is growing. In the 5 years since NIH enacted its pioneering Policy on Sex as a Biological Variable (SABV) (see our progress report here), there has been a lot of activity, including increased attention on sex differences and influences and many questions and requests for assistance. I’m pleased to announce the NIH Office of Research on Women’s Health (ORWH) has issued two new courses, Sex as a Biological Variable: A Primer and Bench to Bedside: Integrating Sex and Gender to Improve Human Health, to our suite of free e-learning offerings. Jan...
Source: NIH Extramural Nexus - April 12, 2021 Category: Research Authors: Janine Clayton Tags: blog Open Mike rigor SABV Transparency Source Type: funding