Opportunity Information: Apply for RFA FD14 007
Apply for RFA FD14 007
- The Food Drug Administration in the health science and technology and other research and development sector is offering a public funding opportunity titled "Dissolution Methods for Microsphere and Implant Drug Products" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
- This funding opportunity was created on Apr 7, 2014 and posted on Mar 31, 2014.
- Applicants must submit their applications by May 2, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Public housing authorities/Indian housing authorities Small businesses Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) County governments Independent school districts City or township governments Special district governments State governments For profit organizations other than small businesses Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments).
- Foreign Recipients
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Opportunity Summary:
This FDA funding opportunity focuses on improving how dissolution (in vitro drug release) testing is performed for long-acting parenteral drug products, specifically sustained-release microspheres and implants. In the generic drug approval process, dissolution testing is commonly used to help demonstrate bioequivalence between a proposed generic and the Reference Listed Drug (RLD). For sustained-release injections and implants, small differences in how a product is made can change how the drug is released over time and, as a result, can affect bioavailability. Even when a generic product matches the RLD in inactive ingredients (Q1) and in the amounts of those ingredients (Q2), manufacturing differences can still lead to meaningful differences in product structure and performance. The overarching goal of the project is to study and compare dissolution methods for these complex dosage forms so FDA can develop better, clearer recommendations for assessing bioequivalence in generic parenteral sustained-release products.
The work is organized around three core objectives that build on each other. First, the awardee is expected to create sustained-release formulations that are Q1/Q2 equivalent to a selected reference formulation (either a marketed product or an investigational reference). The key requirement is that these test formulations must be made under different manufacturing conditions, intentionally introducing process-related variability while keeping composition constant. Alongside formulation development, the opportunity emphasizes physicochemical characterization of the resulting microspheres or implants to identify attributes that could plausibly influence in vivo performance. In practical terms, this means measuring and documenting properties that can shift with processing (for example, particle size or distribution for microspheres, porosity, morphology, drug loading uniformity, polymer characteristics, surface properties, and other critical quality attributes tied to release behavior).
Second, before running new dissolution experiments, the project calls for a structured review of existing dissolution and in vitro release methods that are currently used for sustained-release microspheres or implant products (depending on which dosage form is chosen). The deliverable is not just a literature summary, but an evaluation of each method’s strengths and weaknesses, with attention to three decision-critical questions: how well the method can detect differences arising from manufacturing changes, how well it can predict or relate to in vivo performance, and how robust and reproducible the method is in routine use. After this assessment, the project should select the test formulations that show the largest physicochemical differences (especially differences expected to matter for bioavailability) and use them as the most challenging set for method comparison. The dissolution method development is expected to be grounded in realistic considerations: the drug substance and drug product properties, and the physiological environment that drives release for these parenteral sustained-release systems.
Third, the project aims to identify at least one dissolution method that can clearly discriminate among sustained-release formulations that differ due to manufacturing conditions, even though they are Q1/Q2 the same. In other words, FDA is looking for an in vitro release approach that is sensitive enough to pick up process-driven differences, yet stable and reliable enough to be a practical tool. The study is expected to culminate in an analysis comparing the tested methods, again highlighting advantages and disadvantages, and explicitly rating each method on discrimination power, potential to reflect in vivo performance, and robustness. The intended outcome is actionable evidence FDA can use when developing future guidance or recommendations for bioequivalence assessment in generic long-acting injectable microspheres and implants.
From an administrative and funding standpoint, this was a discretionary research opportunity offered by the Food and Drug Administration under Funding Opportunity Number RFA FD14-007, using a Cooperative Agreement mechanism (meaning FDA would typically expect substantial scientific/programmatic involvement during the project rather than a purely hands-off grant). The program falls under CFDA 93.103 (FDA Research). At the time of posting (March 31, 2014), the opportunity anticipated up to five awards, with an estimated total funding level of $1,000,000. Individual awards were expected to fall in a relatively narrow band, with an award floor of $400,000 and an award ceiling of $500,000, and there was no cost sharing or matching requirement. Eligibility was broad, covering many domestic entity types (universities, nonprofits, small businesses, state and local governments, and certain for-profit organizations), and it also allowed foreign recipients. The original and current closing date listed was May 2, 2014, and the opportunity was archived June 1, 2014.
Overall, the opportunity is aimed at a very specific regulatory science gap: for complex long-acting parenteral dosage forms, composition sameness does not guarantee performance sameness, and FDA needs dissolution tools that are both scientifically sound and practically discriminating. By funding comparative method development and testing on Q1/Q2-equivalent products made with different manufacturing conditions, the FDA is trying to build an evidence base that supports more consistent, reliable determinations of bioequivalence for generic microsphere and implant drug products.
FAQs: FDA Cooperative Agreement RFA FD14-007 (Dissolution Testing for Long-Acting Parenteral Products)
What is the main purpose of this FDA funding opportunity?
The opportunity focuses on improving how dissolution (in vitro drug release) testing is performed for long-acting parenteral drug products, specifically sustained-release microspheres and implants. The intent is to generate evidence that helps FDA develop clearer, better recommendations for assessing bioequivalence in generic versions of these complex dosage forms.
Which dosage forms are in scope?
The project targets long-acting parenteral sustained-release products, with emphasis on sustained-release microspheres and sustained-release implants.
Why is dissolution testing important in the generic drug approval process for these products?
Dissolution testing is commonly used to help demonstrate bioequivalence between a proposed generic product and the Reference Listed Drug (RLD). For sustained-release injections and implants, release can extend over long periods, and small manufacturing differences can change the release profile and potentially affect bioavailability.
What regulatory science problem is FDA trying to address?
For complex long-acting parenteral dosage forms, composition sameness does not necessarily guarantee performance sameness. Even if a generic matches the RLD in inactive ingredients (Q1) and the amounts of those ingredients (Q2), differences in manufacturing can still create meaningful differences in product structure and release behavior. FDA is seeking dissolution tools that can detect those process-driven differences and support more consistent bioequivalence evaluations.
What does Q1/Q2 equivalence mean in this opportunity?
Q1 refers to matching the inactive ingredients, and Q2 refers to matching the quantities (amounts) of those ingredients. The project requires test formulations that are Q1/Q2 equivalent to a selected reference formulation, while manufacturing conditions are varied to introduce process-related differences.
What is the overarching technical goal of the project?
To study and compare dissolution methods for sustained-release microspheres or implants and identify at least one in vitro release method that can discriminate among formulations that are Q1/Q2 the same but differ due to manufacturing conditions, while also being robust and practical for routine use.
How is the work organized?
The work is organized into three core objectives that build on each other: (1) create Q1/Q2-equivalent sustained-release formulations made under different manufacturing conditions and characterize them, (2) review and evaluate existing dissolution/in vitro release methods and select the most challenging test formulations for comparison, and (3) identify and compare dissolution methods to find at least one that can clearly discriminate process-driven differences and assess each method’s strengths and weaknesses.
What is required in Objective 1 (formulation development and characterization)?
The awardee is expected to create sustained-release formulations that are Q1/Q2 equivalent to a selected reference formulation (marketed or investigational). The key requirement is that these formulations must be manufactured under different conditions to intentionally introduce process-related variability while keeping composition constant. The project also emphasizes physicochemical characterization to identify attributes that could plausibly influence in vivo performance.
What kinds of physicochemical attributes are mentioned for characterization?
Examples include particle size and particle size distribution (for microspheres), porosity, morphology, drug loading uniformity, polymer characteristics, surface properties, and other critical quality attributes tied to release behavior that may shift with processing.
Why does FDA require manufacturing variability if the composition is held constant?
The purpose is to isolate the impact of manufacturing/process conditions on product structure and release performance. FDA is specifically seeking methods that can detect differences driven by how the product is made, even when Q1/Q2 sameness is maintained.
What is required in Objective 2 (method review and selection of test formulations)?
Before conducting new dissolution experiments, the project calls for a structured review of existing dissolution and in vitro release methods used for sustained-release microspheres or implants (depending on the chosen dosage form). The deliverable must evaluate each method’s strengths and weaknesses and address three decision-critical questions: (1) how well the method detects differences from manufacturing changes, (2) how well it predicts or relates to in vivo performance, and (3) how robust and reproducible it is in routine use.
Is the method review just a literature summary?
No. The opportunity specifically calls for an evaluation of each method’s strengths and weaknesses, focused on discrimination of manufacturing differences, potential linkage to in vivo performance, and robustness/reproducibility.
How does the project choose which formulations to use for method comparison?
After assessing existing methods, the project should select the test formulations that show the largest physicochemical differences, especially differences expected to matter for bioavailability. These become the most challenging set for dissolution method comparison.
What considerations should guide dissolution method development in this project?
The opportunity states that method development should be grounded in realistic considerations, including the drug substance and drug product properties and the physiological environment that drives release for parenteral sustained-release systems.
What is required in Objective 3 (identifying a discriminating dissolution method)?
The project aims to identify at least one dissolution method that can clearly discriminate among sustained-release formulations that differ due to manufacturing conditions while being Q1/Q2 the same. The work should culminate in an analysis comparing tested methods, highlighting advantages and disadvantages, and explicitly rating each method on discrimination power, potential to reflect in vivo performance, and robustness.
What does "discriminating" mean in the context of this opportunity?
It means the in vitro release/dissolution method is sensitive enough to detect differences in release behavior that arise from manufacturing/process changes, even when the formulations have the same inactive ingredients and amounts (Q1/Q2 sameness).
What is the intended outcome for FDA?
The intended outcome is actionable evidence that FDA can use when developing future guidance or recommendations for bioequivalence assessment in generic long-acting injectable microspheres and implants.
What is the Funding Opportunity Number (FON)?
RFA FD14-007.
Which federal agency offered this opportunity?
The Food and Drug Administration (FDA).
What funding mechanism is used?
A Cooperative Agreement mechanism, meaning FDA would typically expect substantial scientific and/or programmatic involvement during the project rather than a purely hands-off grant.
What is the CFDA program associated with this opportunity?
CFDA 93.103 (FDA Research).
How many awards were anticipated?
Up to five awards were anticipated at the time of posting.
What was the estimated total funding level?
The estimated total funding level was $1,000,000.
What were the expected award amounts per project?
Individual awards were expected to be in a narrow range, with an award floor of $400,000 and an award ceiling of $500,000.
Was cost sharing or matching required?
No. There was no cost sharing or matching requirement.
Who was eligible to apply?
Eligibility was broad and included many domestic entity types (universities, nonprofits, small businesses, state and local governments, and certain for-profit organizations). The opportunity also allowed foreign recipients.
What were the application due dates?
The original and current closing date listed was May 2, 2014.
Is this funding opportunity still open?
No. The opportunity was archived on June 1, 2014.
Does the opportunity specify whether the reference formulation must be marketed?
It allows the selected reference formulation to be either a marketed product or an investigational reference.
Does the opportunity require testing both microspheres and implants?
The description frames the review and method work as being for sustained-release microspheres or implant products, depending on which dosage form is chosen.
What types of differences are the dissolution methods expected to detect?
The methods are expected to detect differences arising from manufacturing/process changes that can alter product structure and performance over time, potentially affecting bioavailability, even when Q1/Q2 composition sameness is maintained.
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