Opportunity Information: Apply for RFA FD 23 013
This grant opportunity, titled "Evaluation of oral modified release drug tablet to support the approval of additional strengths" (RFA FD 23 013), is a Food and Drug Administration (FDA) research funding announcement under the U.S. Department of Health and Human Services. It is aimed at improving the scientific basis and practical approach for approving additional strengths of oral modified-release tablets in the generic drug context, particularly for products submitted through an Abbreviated New Drug Application (ANDA). The award mechanism is a cooperative agreement, which typically means the FDA expects to have substantial involvement during the project, such as participating in technical discussions, aligning on research directions, and helping ensure the work addresses regulatory needs.
The core problem the opportunity addresses comes from how companies demonstrate that multiple strengths of a modified-release tablet (for example, 5 mg, 10 mg, 20 mg) behave the same way in the body and are manufactured in a way that preserves the intended release behavior. The FDA guidance document "Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA" (August 2021) lays out recommendations for showing bioequivalence for additional strengths, especially when it may not be feasible or necessary to run full in vivo bioequivalence studies for every strength. For modified-release products, the FDA places strong emphasis on evidence that all strengths share the same drug release mechanism, have similar dissolution profiles across strengths, and maintain excipient ratios that make sense for the release-controlling design. In practice, the challenge is that modified-release tablets can use different platform technologies (such as hydrophilic matrix systems, osmotic systems, coated multiparticulates compressed into tablets, or other release-controlling architectures), and the rules for what can be safely "scaled" from one strength to another are not always straightforward.
The purpose of the funded project is to identify the critical quality attributes (CQAs) that matter most for different modified-release platform technologies and to determine what formulation and process scaling factors are appropriate when developing additional strengths. CQAs are the measurable physical, chemical, biological, or microbiological properties that need to be within certain limits to ensure product quality and performance. In the modified-release tablet setting, this often ties directly to how the dosage form controls drug release over time. The research is intended to clarify which attributes and formulation relationships are essential to preserving the same release mechanism across strengths, and which changes are acceptable when strength is increased or decreased. That includes, but is not limited to, understanding how excipient-to-drug ratios should be adjusted (or held constant) depending on the technology, and how changes in tablet size, surface area, coating weight gain, polymer content, porosity, or other structural variables can alter dissolution behavior.
The expected outcome is practical knowledge that can be used both by generic drug developers and by FDA reviewers making regulatory decisions. For generic manufacturers, clearer evidence-based scaling principles can reduce development uncertainty, lower the risk of late-stage failure, and help determine when in vivo bioequivalence testing can be reduced or replaced by strong in vitro and formulation-bridging evidence. For regulators, the work is meant to strengthen the scientific foundation behind decisions on whether additional strengths can be approved based on similarity of release mechanism and dissolution, rather than requiring extensive clinical pharmacokinetic studies for each strength. In other words, the project supports the broader goal of making generic development more efficient while still protecting patients by ensuring consistent performance across strengths.
Administratively, this is a discretionary funding opportunity categorized under consumer protection, science and technology, and other research and development. It is listed under CFDA number 93.103. The opportunity was created on December 1, 2022, with an original application closing date of March 15, 2023. The award ceiling is $450,000, and the FDA anticipated making one award, which suggests a single research team or consortium would be selected to carry out the work, likely producing outputs that could influence future guidance interpretation, review practices, or publicly shared scientific recommendations.
Eligibility is broad and includes many types of organizations that can conduct applied pharmaceutical science research. Eligible applicants include state, county, and local governments; public and private institutions of higher education; Native American tribal governments and organizations; public housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (including those other than small businesses); small businesses; and other entities as described in the eligibility clarification text. This wide eligibility list indicates the FDA is primarily focused on obtaining high-quality, relevant research results, regardless of whether the performer is an academic lab, a nonprofit research institute, a private company with specialized formulation expertise, or a multi-organization partnership.
Overall, the grant is best understood as targeted regulatory science: it is not simply basic research on drug delivery, but a project designed to produce concrete, decision-relevant evidence on how to scale modified-release tablet formulations across strengths while maintaining the same release-controlling mechanism and comparable dissolution behavior. The intended impact is improved consistency, predictability, and scientific rigor in demonstrating bioequivalence for additional strengths of generic modified-release oral dosage forms, ultimately supporting both efficient generic competition and robust assurance of therapeutic equivalence.Apply for RFA FD 23 013
- 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 "Evaluation of oral modified release drug tablet to support the approval of additional strengths" 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 Mar 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 $450,000.00 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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