Opportunity Information: Apply for RFA FD 23 016
This grant opportunity (RFA FD 23 016) from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA) supports research aimed at making virtual bioequivalence (VBE) studies more reliable and more usable for evaluating generic drugs. The central goal is to build and demonstrate a practical workflow for designing and running a virtual bioequivalence trial using a physiologically-based pharmacokinetic (PBPK) model, or similarly complex mechanism-based modeling approaches, in a way that can meaningfully detect formulation differences between a reference listed drug (the brand or reference standard product) and a proposed generic product. The emphasis is not just on building a PBPK model, but on using a PBPK model that has been validated for a clearly defined intended purpose and then integrating it into an end-to-end, defensible VBE process.
At its core, the project is meant to answer a common regulatory and scientific challenge: how to use mechanistic modeling and simulation to evaluate whether two formulations behave similarly enough in the body to be considered bioequivalent, without always relying exclusively on traditional in vivo clinical bioequivalence studies. The FDA is looking for a workflow that lays out key design choices, documents assumptions, and addresses sources of uncertainty so that a VBE assessment can be performed consistently and interpreted with confidence. This includes exploring the considerations that become important as model complexity increases, such as PBPK models that represent organs, physiological processes, and drug-specific parameters in a mechanistic way rather than relying only on empirical curve-fitting.
The deliverable implied by the announcement is a structured, reproducible approach that covers the main steps needed for a credible virtual bioequivalence trial. That typically includes defining the context of use and decision question (what product types, what formulation differences, what population), selecting or developing an appropriate PBPK or mechanism-based model, establishing what validation looks like for the intended purpose (for example, demonstrating that the model can predict relevant pharmacokinetic outcomes under conditions that matter for BE), and then using that validated model to simulate virtual trials that can distinguish meaningful formulation differences from noise. A major theme is identifying reasonable assumptions and documenting them, since VBE depends heavily on choices about parameter distributions, variability, population physiology, in vitro to in vivo linkages, and how formulation properties are represented.
The funding mechanism is a cooperative agreement, which generally means substantial involvement from the FDA during the project rather than a hands-off research grant. That structure often indicates the agency expects ongoing coordination, iterative feedback, and alignment with regulatory science needs as the workflow is developed and refined. The activity category is research and development within consumer protection, science, and technology, reflecting the public health relevance of improving generic drug evaluation tools and potentially reducing the need for certain human studies when scientifically justified.
Key administrative details are straightforward: the opportunity was created on December 1, 2022, with an original closing date of February 15, 2023. The award ceiling is $500,000 total, and the FDA expected to make one award, signaling a single, focused project rather than a broad multi-award program. The listing references CFDA number 93.103. Eligibility is broad and includes state, local, and tribal governments; public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit entities (including those other than small businesses); and small businesses, with a note that additional eligibility clarifications may exist in the full announcement.
Overall, the opportunity is best understood as an FDA regulatory science project designed to move VBE using PBPK from an ad hoc or case-by-case exercise toward a well-justified, repeatable workflow. The agency is explicitly interested in how to design the virtual trial itself (for example, virtual population selection, trial size, variability assumptions, and comparison metrics), how to validate the mechanistic model for the specific bioequivalence purpose, and how to ensure the approach can actually detect formulation differences between a reference product and a generic candidate, which is the central regulatory question in generic drug bioequivalence assessment.Apply for RFA FD 23 016
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, science and technology and other research and development sector is offering a public funding opportunity titled "Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models" 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 Dec 01, 2022.
- Applicants must submit their applications by Feb 15, 2023. (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 $500,000.00 in funding.
- The number of recipients for this funding is limited to 1 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, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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| Novel approaches to support therapeutic development in ultra-rare cancers Apply for RFA FD 23 008 Funding Number: RFA FD 23 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,500,000 |
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| Natural History and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional Apply for RFA FD 23 028 Funding Number: RFA FD 23 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,000,000 |
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| Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required Apply for RFA FD 23 001 Funding Number: RFA FD 23 001 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $650,000 |
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| Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials Optional Apply for RFA FD 23 026 Funding Number: RFA FD 23 026 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,000,000 |
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