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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Frequently Asked Questions (FAQs)
What is this funding opportunity about?
This FDA cooperative agreement (U01) supports research to improve how bioequivalence (BE) and therapeutic equivalence (TE) are evaluated for topical generic drugs when the proposed generic is not Q1/Q2 the same as the reference listed drug (RLD). The focus is on building mechanistic, science-based approaches that can reduce reliance on comparative clinical endpoint studies.
Which FDA funding opportunity is this?
The Funding Opportunity Number (FON) is RFA-FD-18-010. The award mechanism is a U01 cooperative agreement under the FDA (HHS), with CFDA number 93.103.
Why is FDA focusing on non-Q1/Q2 topical products?
Many nonclinical alternatives to clinical endpoint BE studies (such as IVRT, IVPT, and physicochemical characterization) have generally been applied when a generic matches the RLD in qualitative ingredients (Q1) and quantitative amounts (Q2). This opportunity targets the scientific gap for compositionally different (non-Q1/Q2) topical formulations, where subtle formulation differences can change skin delivery and performance in ways that are harder to predict.
What does Q1/Q2 sameness mean in this context?
Q1 refers to qualitative sameness (having the same excipients/ingredients as the RLD). Q2 refers to quantitative sameness (having those ingredients in the same amounts). This opportunity specifically addresses cases where a proposed generic is not Q1/Q2 the same as the RLD.
What is the main scientific goal of the project?
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, and to link those properties to measurable delivery outcomes.
Why does the opportunity emphasize that topical products change after application?
The opportunity highlights that topical products can undergo "metamorphosis" on skin (for example, solvent evaporation and drying). These changes can shift phase behavior, alter microstructure, change drug solubility, and affect the drug's thermodynamic activity over time, which in turn can affect drug release and skin uptake.
What is meant by "thermodynamic activity" and why is it important here?
Thermodynamic activity is framed as being closely tied to the driving force for drug release and uptake into skin. The FDA is seeking research that can measure or infer how thermodynamic activity evolves over time in different formulations and connect those time-dependent changes to drug delivery outcomes.
Is thermodynamics the only factor FDA is interested in?
No. The opportunity explicitly notes that thermodynamics alone may not fully explain topical performance. Other potential "failure modes" for BE/TE include physical structure, rheology, phase distribution, polymorphism, partitioning behavior, and diffusion within the vehicle and into skin.
What kinds of topical formulations are awardees expected to study?
Awardees are expected to create systematic "families" of topical formulations that differ in controlled ways. The progression described starts with simpler systems (single-phase solutions), then single-phase gels, and then moves to more complex dosage forms.
What kinds of formulation changes are envisioned?
The opportunity describes both Q2 and non-Q1 changes. Examples include varying the level of a key excipient in stepwise ranges (such as 10, 15, 25, or 50 percent around a nominal level) and substituting similar materials (for example, different polymers, oils, or alcohols).
What attributes should be measured across formulation variants?
The project is expected to 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.
What role does IVPT play in this research program?
In vitro permeation testing (IVPT), typically using human skin, is described as a major experimental pillar. IVPT is used to generate flux profiles over time that represent cutaneous pharmacokinetics (how much drug moves into and through skin as a function of time).
How are IVPT flux profiles expected to be used?
The grant calls for linking IVPT flux profiles to measured formulation characteristics for each variant, including time-resolved profiles of drug thermodynamic activity as the formulation dries or changes after application. The intent is to identify which measurable properties predict skin delivery performance and which differences are not meaningful.
What is the intended outcome for BE/TE assessment?
The desired outcome is a clearer, mechanistically grounded 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.
Does the opportunity consider that the vehicle may affect therapeutic performance?
Yes. The opportunity notes that the "vehicle" (the excipient matrix) may contribute to clinical effect through its own properties or mechanisms. As a result, the research should consider how formulation properties (not only the active ingredient) can influence therapeutic performance.
What are "positive and negative controls for BE" in this program?
The project is expected to include validation using formulations that should be equivalent (positive controls) and formulations that should not be equivalent (negative controls). This is meant to demonstrate that the proposed methods are sensitive enough to detect meaningful differences and specific enough not to flag irrelevant ones.
What makes this award a cooperative agreement (U01)?
As a cooperative agreement, the recipient is expected to work closely with FDA scientists throughout the project. The description indicates collaboration with FDA on selection of drugs and formulation variants, and joint shaping of the research strategy, protocols, study conduct, analysis, and dissemination.
Will FDA be involved in selecting the drugs and formulations studied?
Yes. The opportunity states that drugs and formulation variants are to be selected in collaboration with FDA, consistent with the cooperative agreement structure.
How long-term and systematic is the research expected to be?
The work is described as systematic and multi-year, designed to develop a mechanistic map linking formulation composition to critical quality attributes and ultimately to performance.
How could the results be used by FDA and industry?
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, potentially reducing reliance on costly and slow clinical endpoint BE studies.
How many awards are expected and what is the funding cap?
The listing states an expected number of awards of 2, with an award ceiling of $250,000.
Who is the sponsoring agency?
The agency is the U.S. Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS).
What was the original closing date for the opportunity?
The original closing date listed is May 21, 2018.
Who is eligible to apply based on the listing?
Eligibility is broad and 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.
Is this opportunity limited to academic institutions?
No. Based on the eligibility list provided, academic institutions are eligible, but so are governments, nonprofits, for-profit organizations (including small businesses), tribes/tribal organizations, and individuals.
What kinds of BE approaches is FDA trying to advance beyond clinical endpoint trials?
The opportunity references in vitro release testing (IVRT), in vitro permeation testing (IVPT), and detailed physicochemical characterization as efficient, science-based alternatives that FDA has been moving toward, and seeks to extend the scientific foundation of such approaches to non-Q1/Q2 products.
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