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

Food and Drug Administration

Description

This grant opportunity aims to fund research and development of non-invasive technologies to measure how a topically applied drug is absorbed in the skin. The goal is to create an accurate and reliable method to monitor the presence of the drug at various depths within the skin over time. This technique will help in understanding how drugs are absorbed by the skin and support the development of a new approach to demonstrate the bioequivalence of topical products, ensuring they are effective …

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…

Source

Grant ID

FOR-FD-24-004

Funding Source

Food and Drug Administration

Eligibility

The following categories of applicants are invited to apply:

  • Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
  • For profit organizations other than small businesses
  • Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
  • Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
  • State governments
  • Public and State controlled institutions of higher education
  • Special district governments
  • County governments
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Native American tribal governments (Federally recognized)
  • Private institutions of higher education
  • Others (see text field entitled "Additional Information on Eligibility" for clarification)
  • Independent school districts
  • Small businesses
  • Public housing authorities/Indian housing authorities
  • City or township governments
Additional Eligibility Information
Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the NIH or FDA will not accept:•A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.•A resubmi…
Awards & Funding

Award Ceiling

$250,000

Award Floor

$250,000

Funding Amount

Discretionary

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