Opportunity Information: Apply for RFA FD 18 010
This FDA cooperative agreement (U01) funding opportunity focuses on a persistent problem in topical generic drug development: proving bioequivalence (BE) and therapeutic equivalence (TE) when a proposed generic topical product is not Q1/Q2 the same as the reference listed drug (RLD). For many topical products, FDA has been moving toward efficient, science-based alternatives to comparative clinical endpoint studies, such as in vitro release testing (IVRT), in vitro permeation testing (IVPT), and detailed physicochemical characterization. But those approaches have generally been limited to cases where the generic matches the RLD in qualitative ingredients (Q1) and quantitative amounts (Q2), because sameness reduces the likelihood that subtle formulation differences will create meaningful performance differences on skin. This grant is aimed at breaking through that limitation by building the scientific foundation needed to evaluate BE for compositionally different (non-Q1/Q2) topical formulations using rigorous, mechanistically grounded methods rather than routine clinical endpoint trials.
The core objective is to develop accurate, sensitive, and reproducible ways to characterize the dynamic thermodynamic and functional properties of topical dosage forms that govern drug delivery to and within the skin. A key emphasis is that topical products do not stay static after application: they undergo "metamorphosis" on skin, such as solvent evaporation and drying, which can shift phase behavior, change drug solubility, alter microstructure, and ultimately change the thermodynamic activity of the drug. Because thermodynamic activity is closely tied to the driving force for drug release and skin uptake, the FDA is seeking research that can measure or infer how that activity evolves over time in different formulations, and then connect those measurements to actual delivery outcomes. The opportunity also explicitly recognizes that thermodynamics alone may not fully explain performance; physical structure, rheology, phase distribution, polymorphism, partitioning behavior, and diffusion within the vehicle and into skin can all act as failure modes for BE/TE if they diverge between formulations.
The work envisioned is systematic and multi-year, designed to create a mechanistic map linking formulation composition to critical quality attributes and, ultimately, to performance. Awardees are expected to create families of topical formulations that differ in controlled ways, starting with simpler systems (single-phase solutions), then moving to single-phase gels, and then progressing to more complex dosage forms. These variants may include Q2 changes (same excipients, different levels of a key excipient varied in steps such as 10, 15, 25, 50 percent around nominal) and non-Q1 changes (substituting similar materials such as different polymers, oils, or alcohols). For each variant, the project should evaluate how compositional changes influence phase state proportions, drug distribution across phases, polymorphic form, solubility and stability, rheological and structural properties, and other attributes that could alter drug diffusion and partitioning into skin.
A major experimental pillar is IVPT, typically using human skin, to generate flux profiles over time that represent cutaneous pharmacokinetics (how much drug moves into and through skin as a function of time). The grant calls for linking those IVPT flux profiles to the formulation characteristics measured for each variant, including time-resolved profiles of drug thermodynamic activity as the formulation dries or otherwise changes post-application. In other words, the goal is not just to measure differences, but to identify which measurable properties are truly predictive of skin delivery performance and which differences are inconsequential. This is where the thermodynamic framing is meant to help: if two different formulations can be shown to maintain similar "driving force" and relevant structural/transport conditions over the application period, then the risk of BE/TE failure may be mitigated even without Q1/Q2 sameness.
Another important component is validation using positive and negative controls for BE. The project is expected to test formulations that should be equivalent and formulations that should not be equivalent, to confirm that the proposed characterization methods are sensitive enough to detect meaningful differences and specific enough not to flag irrelevant ones. The outcome the FDA is looking for is a clearer understanding of which formulation characteristics must remain similar, even across compositionally different products, to ensure equivalent rate and extent of drug availability at or near the site of action in the skin. This includes the possibility that the "vehicle" (the excipient matrix) can contribute to clinical effect through its own properties or mechanisms, so the research should consider not only the active ingredient but also how the formulation itself can influence therapeutic performance.
Structurally, this is a cooperative agreement, meaning the recipient is expected to work closely with FDA scientists throughout the project. Drugs and formulation variants are to be selected in collaboration with FDA, and the research strategy, protocols, study conduct, analysis, and dissemination of results are intended to be jointly shaped through that collaboration. The program is positioned to generate publishable, generalizable scientific principles and practical evaluation approaches that could eventually inform regulatory standards or product-specific guidance for non-Q1/Q2 topical generics, reducing reliance on costly, slow, and higher-risk clinical endpoint BE studies.
Key administrative details from the listing include: Funding Opportunity Number RFA-FD-18-010; instrument type U01 cooperative agreement; agency FDA within HHS; CFDA number 93.103; expected number of awards 2; award ceiling $250,000; original closing date May 21, 2018; and broad eligibility that includes federal-recognized tribes and tribal organizations, state and local governments, public and private institutions of higher education, nonprofits (with and without 501(c)(3) status), for-profit organizations (including small businesses), and individuals.Apply for RFA FD 18 010
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Bioequivalence of Topical Products: Elucidating the Thermodynamic and Functional Characteristics of Compositionally Different Topical Formulations (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Mar 21, 2018.
- Applicants must submit their applications by May 21, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, Individuals, For profit organizations other than small businesses, Small businesses.
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| Funding Opportunity |
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| Formulation drug product quality attributes in dermal physiologically-based pharmacokinetic models for topical dermatological drug products and transdermal delivery systems (U01) Apply for RFA FD 18 019 Funding Number: RFA FD 18 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Three-Dimensional Approach for Modeling Nasal Mucociliary Clearance via Computational Fluid Dynamics (CFD) (U01) Apply for RFA FD 18 020 Funding Number: RFA FD 18 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $280,000 |
| Computational fluid dynamics (CFD) and discrete element modeling (DEM) approach for predictions of dry powder inhaler (DPI) drug delivery (U01) Apply for RFA FD 18 014 Funding Number: RFA FD 18 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $380,000 |
| Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Non-Invasive Techniques (U01) Apply for RFA FD 18 012 Funding Number: RFA FD 18 012 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Renewal Applications: Centers of Excellence in Regulatory Science and Innovation (U01) Apply for RFA FD 18 011 Funding Number: RFA FD 18 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| Assuring Radiation Protection (U18) Apply for RFA FD 18 021 Funding Number: RFA FD 18 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $400,000 |
| Exploration of HL7 FHIR Standards for Clinical Research and Post-market Surveillance (U24) Apply for RFA FD 18 016 Funding Number: RFA FD 18 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFD FD 18 018 Funding Number: RFD FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Cooperative Agreement to Support the Food and Agriculture Organization (FAO) (U01) Apply for RFA FD 18 009 Funding Number: RFA FD 18 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act Apply for RFA FD 18 013 Funding Number: RFA FD 18 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,200,000 |
| Strengthen Regulatory Systems to Ensure the Safety and Quality of Food and Medical Products (U01) Apply for RFA FD 18 022 Funding Number: RFA FD 18 022 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,500,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U19) Apply for RFA FD 18 025 Funding Number: RFA FD 18 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,000,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFA FD 18 018 Funding Number: RFA FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Strengthening Global Competency and Capacity in Inspectional Approaches and Good Manufacturing Practices (GMP) (U01) Apply for RFA FD 18 024 Funding Number: RFA FD 18 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Minor Use Minor Species Development of Drugs (R01) Apply for PAR 18 827 Funding Number: PAR 18 827 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| Request for Information (RFI): FDA Standard Core Clinical Outcome Assessments and Endpoints Apply for RFI NOT FD 18 014 Funding Number: RFI NOT FD 18 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 002 Funding Number: RFA FD 19 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) Clinical Trial Optional Apply for RFA FD 19 005 Funding Number: RFA FD 19 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01- Clinical Trial Required) Activity Code Apply for RFA FD 19 014 Funding Number: RFA FD 19 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 008 Funding Number: RFA FD 19 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
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