Evaluation of Dissolution Methods for Complex Parenteral Dosage Forms (U01) | Apply Online

Opportunity Summary:

The FDA funding opportunity RFA-FD-13-019, titled "Evaluation of Dissolution Methods for Complex Parenteral Dosage Forms (U01)," is a cooperative agreement aimed at improving how complex injectable (parenteral) drug products are evaluated in the lab. The program is motivated by a practical regulatory and scientific gap: even though more and more injectable medicines are being formulated as complex systems such as polymeric micelles, liposomes, nanosuspensions, and related nanomedicine or carrier-based platforms, there still are not widely accepted compendial methods (for example, standardized pharmacopeial tests) or truly biorelevant in vitro drug release assays that can be consistently used across products. In other words, the field lacks reliable, standardized lab tests that can measure drug release from these complex formulations in a way that is meaningful for product comparison and regulatory decisions.

The core purpose of the proposed research is to evaluate existing in vitro release and dissolution-style methods for these complex parenteral dosage forms and to determine how well those methods actually perform in the contexts that matter most for regulation and product development. The announcement specifically emphasizes three performance questions. First, can the method detect formulation differences, meaning can it distinguish between products that are not truly the same in critical attributes like composition, particle characteristics, or drug-carrier interactions. Second, does the method help predict in vivo performance, meaning whether the in vitro release behavior correlates with what happens in patients or relevant animal models, such as release rate, exposure profiles, or therapeutic outcomes. Third, is the method robust, meaning it produces consistent, reproducible results under normal variations in testing conditions, operators, equipment, and laboratories. Together, these aims reflect a push to identify and characterize methods that are not just scientifically interesting, but dependable enough to support regulatory review and potentially broader standardization.

The larger public-health and regulatory impact described in the opportunity is centered on generic drug access and product quality. Complex parenteral products are often expensive and technically challenging to replicate, and uncertainty around appropriate in vitro release testing can slow development, complicate equivalence assessments, and lengthen regulatory review. By rigorously evaluating current in vitro release methodologies and their strengths and limitations, the program is intended to advance the FDA regulatory review process for complex parenteral drug products. The downstream goal is to support the availability of high-quality generic versions of these complex injectables, ultimately improving affordability and access for the U.S. public while maintaining strong quality standards.

Administratively, this opportunity was issued by the U.S. Food and Drug Administration under the activity category of Consumer Protection: Food and Nutrition: Health, and it uses the cooperative agreement mechanism (U01). A cooperative agreement indicates that the FDA expects to have substantial involvement during the project compared with a standard grant, typically through collaboration, scientific steering, or programmatic oversight as the work progresses. The program anticipated making two awards, with an estimated total funding level of $1,000,000. The maximum award amount (award ceiling) was listed as $500,000. No cost sharing or matching was required, which reduces barriers for applicants by not requiring them to provide non-federal funds to support the project.

The eligibility list was broad and included many types of organizations, such as public and private institutions of higher education, nonprofits (including both 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (other than small businesses), small businesses, and multiple levels of government (state, county, city/township, special district), as well as tribal governments and tribal organizations. Importantly, foreign participation was explicitly allowed: non-U.S. entities were eligible to apply, non-U.S. components of U.S. organizations were eligible, and foreign components as defined by HHS policy were permitted. This reflects the global nature of advanced drug delivery research and acknowledges that relevant technical expertise may be distributed internationally.

Key dates indicate that the opportunity was posted on April 3, 2013, with an original and current closing date of May 24, 2013, and an archive date of June 23, 2013. The associated CFDA number is 93.103, under the Food and Drug Administration research assistance listing. For applicants or interested parties who needed help accessing the full announcement, the notice provided a grants management contact, Lisa Ko (lisa.ko@fda.hhs.gov), and referenced an additional information link to the full NIH Guide for Grants and Contracts posting for RFA-FD-13-019.

In practical terms, the solicitation is about stress-testing and benchmarking the tools used to measure drug release from sophisticated injectable formulations, with an emphasis on methods that can separate meaningful formulation differences, connect lab data to real-world biological performance, and hold up under routine use. The intended outcome is not merely academic publications, but clearer, stronger scientific foundations for how complex parenteral drug products are compared and reviewed, helping regulators and developers move toward consistent standards that support safe, effective, and more accessible generic competition.

Browse more opportunities from the same agency: Food Drug Administration

Browse more opportunities from the same category: Consumer Protection Food and Nutrition Health

Next opportunity: AHRQ Patient Centered Outcomes Research (PCOR) Mentored Research Scientist Development Award (K01)

Previous opportunity: New York Conservation Innovation Grants

USGrants.org Applicant Portal:

Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.

Apply for RFA FD 13 019

 

[Watch] how do funding administrators access proposals?

Applicants also applied for:

Applicants who have applied for this opportunity (RFA FD 13 019) also looked into and applied for these:

 

Grant application guides and resources

It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!

Apply for Grants

 

 

Premium leads for funding administrators, grant writers, and loan issuers

Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.

If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.

Subscribe to Leads

 

Request more information:

Would you like to learn more about this funding opportunity, similar opportunities to "RFA FD 13 019", eligibility, application service, and/or application tips? Submit an inquiry below:

Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.