Opportunity Information: Apply for RFA FD 18 012
The FDA funding opportunity "Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Non-Invasive Techniques (U01)" is aimed at solving a long-standing problem in generic topical drug development: proving bioequivalence (BE) in a way that is accurate, sensitive, reproducible, and practical. For many drugs that act systemically, BE can be shown by comparing plasma pharmacokinetics (PK), which regulators view as a strong and efficient standard. Topical products are different because the drug is intended to act locally in skin tissue, and measuring drug levels at the site of action (typically the epidermis and sometimes the dermis) is far more difficult than drawing blood and running standard PK analyses. While an in vitro pathway exists through in vitro permeation testing (IVPT) using excised human skin in diffusion cells, there is still no broadly established in vivo cutaneous PK method that regulators can rely on for topical BE, and that gap slows down generic development and keeps clinical endpoint studies in play for many products.
The central objective of this cooperative agreement is to support the development of non-invasive spectroscopic and imaging-based approaches that can monitor and compare how much drug gets into the skin over time after topical application, effectively generating cutaneous PK profiles. The goal is not just to create attractive images, but to build a method that can quantify or at least semi-quantify the rate and extent of drug availability at or near the therapeutic target within skin. The program is meant to advance both the underlying science (how these optical or spectroscopic signals behave in skin, what can realistically be measured, and under what conditions) and the practical study designs needed to evaluate BE between a test generic and a reference listed drug (RLD) or reference standard (RS). The end state the FDA is pushing toward is a technique that could ultimately be used with commercially available topical products in human subjects, without needing invasive sampling or drug modification.
A major theme running through the opportunity is overcoming technical barriers that currently prevent imaging or spectroscopy from serving as dependable PK tools in skin. Skin itself produces signal interference that can mask or distort the signal from a drug, so applicants are expected to develop strategies to separate drug signal from background tissue signal and to calibrate signal intensity in a way that supports comparisons between products. The FDA highlights that approaches relying on chemical modification of the active ingredient, such as deuteration, are generally misaligned with the practical regulatory goal because BE needs to be demonstrated for the marketed, commercially formulated drug products as they are actually sold and used. Another challenge the solicitation calls out is depth: as measurements go deeper into skin, signal attenuation typically increases, so the program seeks methods that can either accurately measure at meaningful depths (epidermis and possibly dermis) or provide correction strategies that account for depth-related signal loss. Related to this is the desire to learn whether a given technology can provide not just total signal but meaningful information about drug distribution and localization within layers of skin, since where the drug resides can matter as much as how much is present.
The research scope is intentionally broad on the technology side, but tightly focused on demonstrating BE-relevant performance. Proposed work is expected to identify or develop non-invasive techniques (for example, spectroscopy, imaging, or tomography-based methods) that are accurate, sensitive, and reproducible for characterizing cutaneous PK after topical dosing. Applicants are expected to think through practical measurement issues such as temporal resolution (how frequently you can measure changes over time), spatial resolution (how finely you can map drug presence across an area), and the orientation and size of the measurement region (since topical application is inherently heterogeneous). The program also expects teams to define the limitations of their selected methods, including which drug chemistries are measurable with a given modality, which formulations might cause interference, and when a method can only provide semi-quantitative rather than fully quantitative outputs. In other words, part of success is clearly delineating what the method can and cannot do, and then building a convincing proof-of-principle around realistic use cases.
A defining feature of the opportunity is that it is a U01 cooperative agreement, meaning substantial FDA scientific involvement is built into the project. The awardee is expected to work collaboratively with FDA scientists to refine the research plan, align study designs and protocols with regulatory needs, coordinate study conduct, analyze the resulting data, and publish findings. The multi-year structure is deliberate because the FDA anticipates that meaningful progress will require technology development, extensive characterization, and multiple iterative studies rather than a single experiment. Drugs and product sets are to be selected in collaboration with the FDA, and may include cases where clinical endpoint BE studies already exist, as well as sets that can serve as positive controls (products believed to be bioequivalent) and negative controls (products expected not to be bioequivalent). That control framework is important because the program is not simply about detecting drug in skin; it is about demonstrating that the method can reliably show BE when BE is truly present and, just as importantly, can discriminate when BE is not present.
The deliverable the FDA is implicitly driving toward is a non-invasive cutaneous PK methodology that can generate time-course profiles from which meaningful PK endpoints could be derived and used in BE comparisons. The funded research should produce proof-of-principle results that demonstrate discrimination sensitivity (the ability to detect real differences between products when they exist) and reproducibility (the ability to get consistent results across repeats, subjects, sites, and time). The FDA also signals an interest in cross-validation across groups and technologies: FDA collaborators may ask independent research teams to align key study parameters like products, dose amount, and dose duration so results from different non-invasive techniques can be compared or corroborated. In practical terms, the opportunity is designed to move the field closer to a regulatory-usable in vivo approach for topical BE, reducing reliance on expensive and variable clinical endpoint trials and enabling more efficient development and approval of generic topical medicines.
From an administrative standpoint, this opportunity (RFA-FD-18-012) is offered by the Department of Health and Human Services, Food and Drug Administration, under a cooperative agreement funding instrument. The program listed an award ceiling of $250,000 and anticipated making two awards. Eligibility is broad, spanning government entities, tribal organizations, public and private higher education institutions, nonprofits (with and without 501(c)(3) status), for-profit organizations (including small businesses), which reflects the FDA's intent to attract a mix of academic laboratories, technology developers, and applied research groups capable of both engineering development and rigorous bioanalytical validation. Although the original closing date was June 4, 2018, the scientific framing remains a clear snapshot of what the FDA views as the key hurdles and the kinds of evidence needed to turn non-invasive skin measurements into a credible, BE-focused tool for topical drug products.Apply for RFA FD 18 012
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Non-Invasive Techniques (U01)" 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 Mar 23, 2018.
- Applicants must submit their applications by Jun 04, 2018. (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 $250,000.00 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.
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| Funding Opportunity |
|---|
| Renewal Applications: Centers of Excellence in Regulatory Science and Innovation (U01) Apply for RFA FD 18 011 Funding Number: RFA FD 18 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| Assuring Radiation Protection (U18) Apply for RFA FD 18 021 Funding Number: RFA FD 18 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $400,000 |
| Exploration of HL7 FHIR Standards for Clinical Research and Post-market Surveillance (U24) Apply for RFA FD 18 016 Funding Number: RFA FD 18 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFD FD 18 018 Funding Number: RFD FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Cooperative Agreement to Support the Food and Agriculture Organization (FAO) (U01) Apply for RFA FD 18 009 Funding Number: RFA FD 18 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act Apply for RFA FD 18 013 Funding Number: RFA FD 18 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,200,000 |
| Strengthen Regulatory Systems to Ensure the Safety and Quality of Food and Medical Products (U01) Apply for RFA FD 18 022 Funding Number: RFA FD 18 022 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,500,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U19) Apply for RFA FD 18 025 Funding Number: RFA FD 18 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,000,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFA FD 18 018 Funding Number: RFA FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Strengthening Global Competency and Capacity in Inspectional Approaches and Good Manufacturing Practices (GMP) (U01) Apply for RFA FD 18 024 Funding Number: RFA FD 18 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Minor Use Minor Species Development of Drugs (R01) Apply for PAR 18 827 Funding Number: PAR 18 827 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| Request for Information (RFI): FDA Standard Core Clinical Outcome Assessments and Endpoints Apply for RFI NOT FD 18 014 Funding Number: RFI NOT FD 18 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 002 Funding Number: RFA FD 19 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) Clinical Trial Optional Apply for RFA FD 19 005 Funding Number: RFA FD 19 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01- Clinical Trial Required) Activity Code Apply for RFA FD 19 014 Funding Number: RFA FD 19 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 008 Funding Number: RFA FD 19 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (U01 Clinical Trial Required) Apply for RFA FD 19 009 Funding Number: RFA FD 19 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 010 Funding Number: RFA FD 19 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Cooperative Agreement to Support the Illinois Institute of Technology's Institute for Food Safety and Health (U19 Clinical Trial Optional) Apply for RFA FD 19 003 Funding Number: RFA FD 19 003 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $10,000,000 |
| Enhancing Regulatory Science for the Risk Based Quality Assessment of Complex Products (U01) - Clinical Trials Optional Apply for RFA FD 19 011 Funding Number: RFA FD 19 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
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