Opportunity Information: Apply for RFA FD 23 014
This funding opportunity, titled "In Vitro Based Approaches to Evaluate the Bioequivalence of Prospective Generic Rectal and Vaginal Products (U01) Clinical Trial Not Allowed" (RFA-FD-23-014), is a discretionary cooperative agreement offered by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA). It focuses on advancing scientific methods for demonstrating bioequivalence (BE) for prospective generic rectal and vaginal topical drug products using laboratory-based (in vitro) approaches rather than clinical trials. The central aim is to better define and address the unique scientific and regulatory challenges involved in evaluating BE for these locally acting products, where traditional blood-level pharmacokinetic studies are often not appropriate, sensitive, or feasible.
A main priority of the program is the development and refinement of biorelevant performance tests. In practical terms, that means building test methods that better reflect real-world conditions in the rectal and vaginal environments, such as local physiology, fluid composition, pH, mucus presence, anatomical constraints, and how products spread, dissolve, release drug, and potentially permeate into local tissues. The intent is to strengthen "product characterization-based" BE approaches, meaning BE determinations that rely on a combination of formulation and physicochemical characterization, in vitro release or performance testing, and other mechanistic data that can collectively support equivalence without requiring human efficacy trials.
The award mechanism is a U01 cooperative agreement, which typically indicates substantial involvement or partnership with the FDA during the project. While the exact nature of that involvement can vary, cooperative agreements generally imply ongoing scientific coordination, milestones, and regular communication with the agency to ensure the resulting tools and data are aligned with regulatory needs and can realistically inform BE standards and guidances. The opportunity explicitly does not allow clinical trials, reinforcing that the supported work should remain focused on in vitro methods, laboratory testing frameworks, and potentially associated modeling or analytical strategies that do not cross into interventional human studies.
Funding details include an award ceiling of $1,000,000 per award, with an expectation of two awards. The original closing date for applications was March 31, 2023, and the funding opportunity was created on December 12, 2022. The program is listed under CFDA number 93.103 and is categorized under consumer protection, science and technology, and other research and development, reflecting FDA's public health mission to improve access to high-quality generics while maintaining standards for safety and effectiveness.
Eligibility is broad and includes many types of domestic entities: state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other entities as clarified in the full eligibility text. This wide eligibility suggests FDA is looking to draw from diverse scientific capabilities across academia, industry, and public-sector research environments.
Overall, the opportunity is aimed at improving the scientific foundation for evaluating generic versions of rectal and vaginal topical products by creating and validating laboratory-based, biorelevant performance tests and related characterization strategies. The expected public health impact is a clearer, more reliable pathway for demonstrating bioequivalence without clinical trials in cases where in vitro and characterization-based evidence can provide confidence that a generic product will perform the same as its reference product at the site of action.Apply for RFA FD 23 014
- 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 "In Vitro Based Approaches to Evaluate the Bioequivalence of Prospective Generic Rectal and Vaginal Products (U01) Clinical Trial Not Allowed" 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 12, 2022.
- Applicants must submit their applications by Mar 31, 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 $1,000,000.00 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, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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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 |
| Population Pharmacokinetic Modeling of Systemic Pharmacokinetic Data to Inform Bioequivalence in Regional Lung Exposure (U01) Clinical Trial Not Allowed Apply for RFA FD 23 017 Funding Number: RFA FD 23 017 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $500,000 |
| 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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