Opportunity Information: Apply for RFA FD 22 018
This grant opportunity, RFA FD 22 018 from the U.S. Food and Drug Administration (FDA) within the Department of Health and Human Services, focuses on improving the scientific and regulatory foundation for so-called gastro-retentive extended-release oral drug products. These dosage forms are marketed or described as being able to remain in the stomach or upper gastrointestinal (GI) tract longer than typical oral products, with the goal of improving drug absorption and overall bioavailability. The core problem the FDA is trying to address is that, despite these claims, there has been little to no direct in vivo proof demonstrating true gastric retention for these products in humans. As a result, both regulators and generic drug developers face uncertainty about how to evaluate whether a generic version behaves like the reference listed drug in a way that is clinically meaningful and consistent with the product's proposed mechanism.
The project aims to generate direct, visualizable evidence of gastric retention following oral administration by using imaging technologies. In practical terms, the FDA is looking for research proposals that can track and characterize where a gastro-retentive product goes in the GI tract over time and how long it remains in the stomach region, and then compare that behavior between a reference product and its corresponding generic product. The emphasis on imaging suggests methods that can noninvasively monitor location and transit in vivo, producing objective data rather than relying on indirect assumptions inferred from pharmacokinetic profiles alone. The intent is to connect real-world GI residence behavior to how these dosage forms are expected to work, and to determine whether the reference and generic products show comparable retention patterns.
In parallel with in vivo imaging work, the opportunity calls for exploring and developing in vitro testing methods that can better characterize these formulations and potentially predict or correlate with their in vivo behavior. This includes investigating different laboratory test approaches that might capture key performance attributes of gastro-retentive extended-release products, such as swelling, buoyancy, density changes, mechanical integrity under gastric-like conditions, drug release under relevant pH and motility scenarios, and robustness to physiological variability. The FDA is specifically interested in identifying optimal in vitro methodologies that could be practical for prospective generic applicants to use when building evidence packages to support bioequivalence. A notable aspect is the mention of supporting bioequivalence demonstrations not only for a single strength, but potentially for additional strengths of generic products as well, which often requires sound scientific justification and sensitive, discriminating tests.
From a regulatory perspective, the larger goal is to strengthen standards and decision-making for this category of products by grounding evaluations in clearer, more direct evidence. If successful, the work could help clarify what it really means for a product to be "gastro-retentive" in vivo, how much variability is expected, which product attributes matter most, and what kinds of tests are fit-for-purpose when comparing reference and generic formulations. That, in turn, could reduce ambiguity in review and development, improve consistency in regulatory assessments, and potentially lower barriers for generic competition while maintaining confidence in therapeutic equivalence.
The award structure reflects a targeted research effort rather than a broad multi-award program. The funding instrument type is a cooperative agreement, meaning FDA is likely to have substantial involvement during the project period, such as input on study design, milestones, and data interpretation. The opportunity listed an award ceiling of $1,000,000 and an expected number of awards of one, indicating a single, relatively sizable project intended to produce impactful, publishable, and regulator-relevant outcomes. The opportunity was created on January 12, 2022, with an original application closing date of March 31, 2022. The activity aligns with consumer protection, health, and science and technology research and is tied to CFDA number 93.103. Eligibility is described as "Others" with additional clarifications expected in the full announcement, which typically means the applicant pool may include certain research institutions, academic centers, nonprofits, or other organizations that meet FDA's stated criteria.
Overall, the opportunity is aimed at closing a key evidence gap: verifying and characterizing gastric retention in vivo for products that claim gastro-retentive behavior, and translating what is learned into more reliable in vitro tools that generic developers can use to demonstrate bioequivalence. The practical end result the FDA appears to be seeking is a more rigorous, standardized, and scientifically defensible way to evaluate gastro-retentive extended-release drug products across both reference and generic versions, improving confidence in regulatory outcomes and supporting efficient generic drug development.Apply for RFA FD 22 018
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, health, science and technology and other research and development sector is offering a public funding opportunity titled "Investigating the in vivo behavior and in vitro characteristics purportedly gastro-retentive extended release formulation to enhance the regulatory standard of such products" 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 Jan 12, 2022.
- Applicants must submit their applications by Mar 31, 2022. (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 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)
What is the RFA FD 22 018 grant opportunity about?
RFA FD 22 018 is a U.S. Food and Drug Administration (FDA) grant opportunity focused on improving the scientific and regulatory foundation for gastro-retentive extended-release oral drug products. These products are marketed or described as staying in the stomach or upper gastrointestinal (GI) tract longer than typical oral dosage forms to improve absorption and overall bioavailability.
Which federal agency is offering this funding?
The opportunity is offered by the U.S. Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS).
What problem is FDA trying to solve with this project?
FDA is addressing a key evidence gap: although some products claim to be gastro-retentive, there has been little to no direct in vivo proof in humans showing true gastric retention. This creates uncertainty for regulators and for generic drug developers about how to evaluate whether a generic product behaves like the reference listed drug in a clinically meaningful way that matches the product's proposed mechanism.
What does "gastro-retentive extended-release" mean in this context?
In this context, gastro-retentive extended-release oral drug products are formulations intended (or claimed) to remain in the stomach or upper GI tract for a longer period than typical oral products, while releasing drug over time. The goal of that longer residence is typically to improve absorption and bioavailability.
Why is direct in vivo evidence important for these products?
Because pharmacokinetic profiles alone may not directly prove where a product resides in the GI tract, FDA is seeking objective, visualizable in vivo evidence that confirms whether gastric retention actually occurs in humans and how long it lasts. This evidence is expected to reduce reliance on indirect assumptions and strengthen regulatory decision-making.
What types of research activities is FDA looking to support?
The opportunity emphasizes two connected research tracks: (1) in vivo imaging-based studies to track and characterize GI location and stomach residence over time, and (2) development and exploration of in vitro testing methods that better characterize gastro-retentive extended-release formulations and potentially predict or correlate with in vivo behavior.
What does FDA mean by "direct, visualizable evidence" of gastric retention?
FDA is looking for data generated using imaging technologies that can show where a gastro-retentive product is in the GI tract over time and how long it remains in the stomach region after oral administration, producing objective evidence rather than inference.
Are proposals expected to compare a reference product and a generic product?
Yes. A core emphasis is comparing GI residence behavior between a reference product and its corresponding generic product, including whether they show comparable retention patterns consistent with the claimed gastro-retentive mechanism.
What is the role of imaging technologies in this project?
Imaging technologies are expected to be used to noninvasively monitor product location and transit in vivo, track where the product goes in the GI tract over time, and measure how long it remains in the stomach or upper GI region.
What in vitro method development is FDA interested in?
FDA is interested in identifying and developing in vitro testing methods that can better characterize these formulations and potentially predict or correlate with in vivo behavior. This includes laboratory approaches that capture key performance attributes of gastro-retentive extended-release products under gastric-like conditions and physiological variability.
Which formulation or performance attributes are mentioned as candidates for in vitro testing?
The opportunity specifically mentions attributes and behaviors such as swelling, buoyancy, density changes, mechanical integrity under gastric-like conditions, drug release under relevant pH and motility scenarios, and robustness to physiological variability.
How could the in vitro methods be used by generic drug developers?
FDA is specifically interested in practical in vitro methodologies that prospective generic applicants could use in evidence packages to support bioequivalence, including sensitive and discriminating tests that help justify comparability between reference and generic products.
Does the opportunity mention supporting bioequivalence for more than one strength?
Yes. The description notes interest in supporting bioequivalence demonstrations not only for a single strength, but potentially for additional strengths as well, which often requires strong scientific justification and discriminating tests.
What is the broader regulatory goal of this work?
The broader goal is to strengthen standards and decision-making for gastro-retentive extended-release products by grounding evaluations in clearer, more direct evidence. This includes clarifying what "gastro-retentive" means in vivo, understanding expected variability, determining which product attributes matter most, and identifying tests that are fit-for-purpose for comparing reference and generic formulations.
How could this project affect generic competition and regulatory consistency?
If successful, the work could reduce ambiguity in review and development, improve consistency in regulatory assessments, and potentially lower barriers for generic competition while maintaining confidence in therapeutic equivalence.
What is the funding instrument type for this opportunity?
The funding instrument is a cooperative agreement.
What does a cooperative agreement imply for this project?
A cooperative agreement typically means FDA is likely to have substantial involvement during the project period, such as providing input on study design, milestones, and data interpretation.
How much funding is available and how many awards are expected?
The opportunity lists an award ceiling of $1,000,000 and an expected number of awards of one, indicating a single targeted project.
When was the opportunity created and what was the original closing date?
The opportunity was created on January 12, 2022, and the original application closing date was March 31, 2022.
What is the CFDA number associated with this grant?
The opportunity is tied to CFDA number 93.103.
What activity areas does this grant align with?
The activity aligns with consumer protection, health, and science and technology research.
Who is eligible to apply based on the information provided?
Eligibility is described as "Others," with additional clarifications expected in the full announcement. This typically suggests the applicant pool may include certain research institutions, academic centers, nonprofits, or other organizations that meet FDA's stated criteria.
Is this a broad multi-award program or a targeted effort?
It is described as a targeted research effort rather than a broad multi-award program, with a single expected award.
What kinds of outcomes is FDA likely seeking from the funded work?
The described intent is to produce objective in vivo evidence of gastric retention, generate comparative reference-versus-generic data, and translate findings into more reliable in vitro tools and approaches that are practical for generic developers and useful for regulatory evaluation.
How does the opportunity define success in practical terms?
Based on the description, success would look like a more rigorous, standardized, and scientifically defensible way to evaluate gastro-retentive extended-release drug products across reference and generic versions, improving confidence in regulatory outcomes and supporting efficient generic drug development.
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| Physiologically Based Pharmacokinetic Model for Nose-to-Brain Drug Delivery (U01) Clinical Trial Optional Apply for RFA FD 22 016 Funding Number: RFA FD 22 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $600,000 |
| In Vitro Based Approaches to Evaluate the Bioequivalence of Generic Rectal and Vaginal Products Apply for RFA FD 22 014 Funding Number: RFA FD 22 014 Agency: Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
| Development of advanced analytical methods for the characterization of complex generics Apply for RFA FD 22 013 Funding Number: RFA FD 22 013 Agency: Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $300,000 |
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