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

US · MD Food and Drug Administration (HHS-FDA) grant unknown #FOR-FD-24-004

Summary

The Food and Drug Administration (FDA) is seeking research to evaluate the cutaneous (skin-level) pharmacokinetics of topical drug products using a technique called Pharmacokinetic Tomography. This is a U01 cooperative research agreement that requires a clinical trial component. The opportunity is in a forecasted/pre-solicitation stage, indicating the FDA anticipates issuing a formal funding opportunity announcement. The work aims to advance scientific methods for assessing how topical drugs are absorbed and distributed through skin layers, which has implications for drug bioequivalence and regulatory review.

What they want

Applicants are expected to conduct clinical trial research evaluating the cutaneous pharmacokinetics of topical drug products using Pharmacokinetic Tomography. The mechanism of funding is a U01 (cooperative agreement with substantial FDA involvement). A clinical trial is required as part of the research design. Specific protocols, endpoints, and deliverables will be detailed in the forthcoming formal Funding Opportunity Announcement (FOA).
Technical requirements
  • Must conduct a clinical trial as part of the research
  • Must apply Pharmacokinetic Tomography methodology to evaluate cutaneous pharmacokinetics
  • U01 cooperative agreement mechanism — applicants must accommodate substantial federal agency involvement in research direction

Risks & flags

  • Opportunity is in 'forecasted' status — no formal solicitation has been issued yet; limited details available to assess competitiveness
  • Highly specialized technique (Pharmacokinetic Tomography) may favor a narrow pool of researchers with existing infrastructure and expertise
  • U01 mechanism requires substantial FDA programmatic involvement, which may predispose award to institutions with pre-existing FDA research relationships

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541711
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

Evaluating the Cutaneous Pharmacokinetics …
$unknown
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