Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed
ID: 351808Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$0 - $250K

Eligible Applicants

Unrestricted

Funding Category

Food and Nutrition

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/351808

Additional Information

https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-010.html
Timeline
    Description

    The U.S. Food and Drug Administration (FDA) is offering a funding opportunity (NOFO RFA-FD-24-010) aimed at identifying drug-related and formulation-related factors that contribute to alcohol dose dumping (ADD) in modified-release (MR) oral drug products. The objective of this initiative is to develop tools that minimize the potential for ADD, thereby supporting regulatory assessments and enhancing the safety of generic medications. This research is crucial as it addresses the health risks associated with the rapid release of drugs when exposed to alcohol, which can lead to severe side effects. Funding of up to $250,000 is available for one year, with applications due by April 8, 2024. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov for further information.

    Point(s) of Contact
    terrin.brown@fda.hhs.gov
    Files
    Title
    Posted
    RFA-FD-24-010.html
    The U.S. Food and Drug Administration (FDA) is offering a funding opportunity (NOFO RFA-FD-24-010) aimed at identifying factors that lead to alcohol dose dumping (ADD) in modified-release (MR) oral drug products. The proposed research seeks to develop tools that reduce the potential for ADD, thus supporting regulatory assessments and enhancing public access to safe, effective generic medications. The project specifically addresses formulation and drug-related aspects of ADD, emphasizing the importance of understanding how alcohol affects the release of drugs that may pose health risks. Key activities include evaluating various formulation designs, identifying drug attributes, and conducting in vitro assessments using different alcohol concentrations. Funding of up to $250,000 for one year is available, with a potential extension depending on performance. Eligible applicants include higher education institutions, nonprofits, and government entities, with application deadlines set for March 31, 2024. Overall, this initiative seeks to harmonize ADD assessment practices, improving drug safety and mitigating public health risks associated with alcohol consumption.
    Similar Opportunities
    Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering a funding opportunity titled "Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional." This initiative aims to develop and validate an in vitro mechanistic methodology to assess the performance of amorphous solid dispersion (ASD) drug products under various clinically relevant conditions, ultimately enhancing the understanding of how food and acid-reducing agents affect drug absorption. The funding, which ranges from $250,000 to $500,000, is intended to support research that correlates in vitro observations with in vivo outcomes, thereby informing regulatory decisions for high-risk generic oral drug products. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call (240) 402-7610 for further information, with applications being accepted for the fiscal year 2024.
    Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)
    Food and Drug Administration
    The Food and Drug Administration (FDA) is announcing a funding opportunity for a Cooperative Agreement titled "Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)." This initiative aims to support research and development of practices that mitigate risks associated with nitrosamine impurities in human drugs, thereby enhancing public health safety while ensuring access to essential therapeutic drugs. The FDA seeks to fund one award with a total funding amount of $350,000, with no cost-sharing or matching requirements. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or (240) 402-7610 for further information. The opportunity is forecasted for fiscal year 2024, and applicants may submit multiple distinct applications, adhering to guidelines regarding overlapping submissions.
    Collaborations to Enhance Drug Development and Regulatory Science
    Food and Drug Administration
    The Food and Drug Administration (FDA) is inviting applications for a federal grant titled "Collaborations to Enhance Drug Development and Regulatory Science." This opportunity aims to establish cooperative agreements that support Public-Private Partnerships and collaborative activities under the Critical Path Initiative, focusing on innovative projects that enhance drug product development, advanced manufacturing, and the translation of scientific discoveries into therapeutics. The initiative is crucial for fostering innovation in drug safety, efficacy, quality, and performance, with a total funding ceiling of $5 million available for six expected awards in fiscal year 2024. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call (240) 402-7610 for further information.
    Drug Development Tools Research Grants (U01) Clinical Trials Optional
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering Drug Development Tools Research Grants (U01) to support research aimed at advancing drug development tools (DDTs) that have an accepted or reviewable Letter of Intent within the FDA's qualification program. These grants are intended for developers working towards their qualification plan or full qualification package, focusing on tools that can enhance public health by optimizing the drug development process, such as biomarkers or animal models. The funding opportunity provides up to $500,000 for a maximum two-year period, with applications due by May 13, 2024, and May 13, 2025. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov for further information and are encouraged to review the detailed announcement available at https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-030.html.
    Notice of Intent to Publish a Funding Opportunity Announcement for Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use disorder and Alcohol-Associated Organ Damage (R41/R42 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is preparing to publish a Notice of Funding Opportunity (NOFO) aimed at supporting the development of medications for Alcohol Use Disorder (AUD) and Alcohol-Associated Organ Damage (AAOD) through the Investigational New Drug (IND)-enabling and early-stage development process. Eligible applicants, specifically small businesses, are invited to propose projects that advance therapeutic candidates with a solid foundation of background data, facilitating their transition to preclinical and clinical phases of development. This initiative is crucial for addressing the public health challenges associated with alcohol-related conditions, with the NOFO expected to be published on January 16, 2025, and applications due by April 5, 2025. The funding will utilize R41/R42 activity codes, and the estimated award date is September 30, 2025, with project start dates anticipated for December 1, 2025.
    Center for Research on Complex Generics (U18) Clinical Trials Optional
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity for the establishment of a Center for Research on Complex Generics through a cooperative agreement. This initiative aims to enhance collaboration with the generic drug industry, focusing on identifying scientific challenges in generic product development and facilitating research that supports the FDA's mission to improve patient access to high-quality, safe, and effective generic drugs. The Center will serve as a hub for coordination among FDA, academia, and industry stakeholders, conducting research, hosting workshops, and providing public access to research outcomes. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or by phone at 240-402-7610. The funding amount is set at $1.5 million, with one award anticipated for the fiscal year 2025.
    Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01) Clinical Trials Allowed
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a cooperative agreement opportunity titled "Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01)," aimed at advancing research in Anesthesia, Addiction Medicine, and Pain Medicine. Applicants are required to propose comprehensive, evidence-based plans that focus on critical areas such as clinical trial endpoints for chronic pain, outcome measures for stimulant use disorders, and assessments of opioid clinical trials, among others. This initiative is vital for enhancing the understanding and management of analgesics and anesthetics, particularly in vulnerable populations. The FDA anticipates awarding five grants, each with a funding ceiling and floor of $2 million, with applications due for the fiscal year 2025. Interested parties can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610 for further information.
    Notice of Intent to Publish a Funding Opportunity Announcement for Investigational New Drug (IND)-enabling and Early-Stage Development of Medications to Treat Alcohol Use disorder and Alcohol-Associated Organ Damage (R43/R44 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is preparing to publish a Notice of Funding Opportunity (NOFO) aimed at supporting the development of medications for Alcohol Use Disorder (AUD) and alcohol-associated organ damage through the Investigational New Drug (IND)-enabling and early-stage development phases. This funding opportunity is specifically targeted at small businesses that can propose innovative therapeutic agents, with a requirement for applicants to present a therapeutic candidate backed by substantial preliminary data demonstrating its viability for clinical application. The initiative is crucial for advancing potential treatments closer to U.S. Food and Drug Administration (FDA) approval, with the NOFO expected to be published on January 16, 2025, and applications due by April 5, 2025. The estimated award date is September 30, 2025, and projects may begin as early as December 1, 2025, with encouragement for women-owned and socially or economically disadvantaged businesses to apply.
    Utilizing Real-World Data and Algorithmic Analyses to Assess Post-Market Clinical Outcomes in Patients Switching Amongst Therapeutically Equivalent Complex Generic Drug Products and Reference Listed Drugs (U01) Clinical Trial Not Allowed
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering a funding opportunity titled "Utilizing Real-World Data and Algorithmic Analyses to Assess Post-Market Clinical Outcomes in Patients Switching Amongst Therapeutically Equivalent Complex Generic Drug Products and Reference Listed Drugs (U01)." This cooperative agreement aims to develop and test an AI- or ML-based algorithmic model utilizing real-world data to enhance post-market surveillance of complex generic drug products, which are increasingly prevalent in the marketplace and may exhibit distinct differences from their reference listed counterparts. The initiative is critical for ensuring therapeutic equivalence and facilitating timely regulatory actions based on identified post-market signals. Interested applicants can apply for a funding amount of $300,000, with the opportunity being forecasted for fiscal year 2024. For further inquiries, applicants may contact Terrin Brown at terrin.brown@fda.hhs.gov or by phone at 240-338-7494.
    Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a federal grant opportunity titled "Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional." This initiative aims to develop physiologically based pharmacokinetic (PBPK) models to establish mechanistic in vitro in vivo correlations (IVIVCs) for long-acting injectables, specifically crystalline suspensions and polymer-based implants, by analyzing their unique characteristics and formulation attributes. The project is significant for enhancing the understanding of drug release mechanisms and disposition characteristics, ultimately contributing to safer and more effective drug formulations. Interested applicants, including independent school districts, public housing authorities, and non-domestic entities, can apply for a total estimated funding of $600,000, with an award ceiling of $300,000 for up to two awards. For further inquiries, contact Terrin Brown, Grants Management Specialist, at Terrin.Brown@fda.hhs.gov or call 240-402-7610.