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.