Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)
ID: 351126Type: Forecasted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$250K - $250K

Eligible Applicants

Unrestricted

Funding Category

Consumer Protection

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/351126
Timeline
    Description

    The Food and Drug Administration (FDA) is forecasting a funding opportunity titled "Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography," which requires a clinical trial. This cooperative agreement aims to support research and development of non-invasive technologies to accurately measure the pharmacokinetics of topically applied drugs within the skin, facilitating the demonstration of bioequivalence for topical products. The FDA anticipates awarding one grant with a funding amount of $250,000, and interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or by phone at 240-338-7494 for further details. Applications are due in fiscal year 2024, and organizations may submit multiple distinct applications, adhering to specific submission guidelines.

    Point(s) of Contact
    Terrin Brown Grantor
    (240) 338-7494
    terrin.brown@fda.hhs.gov
    Files
    No associated files provided.
    Similar Opportunities
    Collaborations to Enhance Drug Development and Regulatory Science
    Active
    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.
    Critical Path Public Private Partnerships Clinical Trials Optional
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a grant opportunity titled "Critical Path Public Private Partnerships Clinical Trials Optional," aimed at supporting the continuation of existing consortia groups established by the Critical Path Institute. This initiative seeks applications to manage and maintain these groups, fostering innovative projects in research, education, and outreach to enhance drug product innovation and accelerate the development of therapeutics. The grant, which has an award ceiling and floor of $20 million, is expected to result in one award, with applications being accepted for the fiscal year 2024. Interested applicants can contact Terrin Brown at terrin.brown@fda.hhs.gov or (240) 402-7610 for further information.
    OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering a grant opportunity titled "OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed." This initiative aims to enhance the FDA's Office of Minority Health and Health Equity (OMHHE) efforts by funding research and community-based strategies that promote education and public awareness regarding the risks associated with over-the-counter skin lightening products containing hydroquinone and/or mercury. The grant, which has a fixed award amount of $250,000, is open to unrestricted applicants and is part of the fiscal year 2024 funding cycle. Interested parties can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610 for further information.
    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
    Active
    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.
    OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is offering a funding opportunity titled "OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed." This cooperative agreement aims to enhance the FDA's Office of Minority Health and Health Equity (OMHHE) initiatives by promoting education, outreach, and public awareness regarding the use and potential risks associated with skin lightening products, such as hydroquinone. The funding is crucial for developing innovative, community-based strategies that will strengthen the scientific foundation for public health education on this topic. Interested applicants can apply for a funding amount of $250,000, with the opportunity forecasted for fiscal year 2025. For further inquiries, applicants may contact Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610.
    Center for Research on Complex Generics (U18) Clinical Trials Optional
    Active
    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.
    Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional
    Active
    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.
    Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)
    Active
    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.
    Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01) Clinical Trials Allowed
    Active
    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.
    Applied regulatory science research to evaluate and treat cardiotoxicity of oncology therapeutics
    Active
    Food and Drug Administration
    The Food and Drug Administration (FDA) is forecasting a funding opportunity for applied regulatory science research aimed at evaluating and treating cardiotoxicity associated with oncology therapeutics. This initiative seeks to support research that enhances the detection, monitoring, and treatment of cardiotoxicity, with specific interests in standardizing definitions, utilizing biomarkers and imaging, and developing innovative treatment approaches. The FDA anticipates awarding two cooperative agreements under this discretionary grant, with no cost-sharing requirements, and encourages unrestricted applicants to engage in collaborative networks to share data and insights. Interested parties can contact Terrin Brown at terrin.brown@fda.hhs.gov or by phone at 240-402-7610 for further information, with the funding opportunity expected to be available in fiscal year 2025.