The Food and Drug Administration (FDA) is forecasting a funding opportunity titled "Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography," which requires a clinical trial. This cooperative agreement aims to support research and development of non-invasive technologies to accurately measure the pharmacokinetics of topically applied drugs within the skin, facilitating the demonstration of bioequivalence for topical products. The FDA anticipates awarding one grant with a funding amount of $250,000, and interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or by phone at 240-338-7494 for further details. Applications are due in fiscal year 2024, and organizations may submit multiple distinct applications, adhering to specific submission guidelines.

The purpose of this funding opportunity is to support the research and development necessary to advance non-invasive (e.g., quantitative tomography-based) technologies, including the development of apparatus, methods, study designs, and methods of data analysis, to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin in vivo. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, in vivo cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products. 

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