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Federal Grant · Food and Drug Administration

Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)

Last verified by NonDilute: 2026-04-29. Official notice and agency instructions control.

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The pitch

If you have clinical trial capability and expertise in dermatology or topical drug imaging, the FDA will fund your team to validate a novel method for measuring how drugs move through skin.

Award range
Unspecified
Closes
Open date
Nov 24, 2023
Difficulty
High
Source
Grants.gov
Agency
Food and Drug Administration
Last verified
2026-04-29
Fit language
Possible fit only
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What this is

The FDA is seeking research teams to develop and validate pharmacokinetic tomography (a specialized imaging method) for measuring drug penetration and kinetics in skin following topical application. This U01 mechanism requires a mandatory clinical trial component, making it suitable for established research groups with clinical infrastructure. The work directly supports FDA's regulatory science mission to improve topical drug product evaluation and approval processes.

Who can apply

Likely restricted to institutions capable of conducting FDA-regulated clinical trials (universities, research hospitals, established biotech/pharma with clinical operations). Solo founders and early-stage startups without clinical infrastructure are not a good fit. Specific eligibility details (budget caps, geographic limits, org type restrictions) are not provided in the source.

Topics: topical drug delivery · pharmacokinetic imaging · skin penetration · clinical trial · FDA regulatory science · drug kinetics

Public-source funding discovery only. This summary is generated from public agency data and may be incomplete or stale. NonDilute is not affiliated with, endorsed by, or acting on behalf of any government agency. Official notices and agency instructions control. NonDilute does not determine eligibility, provide grant-writing advice, or guarantee funding.