Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)
ID: 351806Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$0 - $250K

Eligible Applicants

Unrestricted

Funding Category

Food and Nutrition

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
  1. 1
    Forecast Posted Not available
  2. 2
    Forecast Due Not available
  3. 3
    Posted Jan 15, 2024 12:00 AM
  4. 4
    Due Apr 8, 2024 12:00 AM
Description

The Food and Drug Administration (FDA) has posted a funding opportunity titled "Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)". This opportunity falls under the category of Food and Nutrition and is a Cooperative Agreement. The funding opportunity does not require cost sharing or matching.

The purpose of this funding opportunity is to support research and development in non-invasive technologies that can 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 goal is to develop an accurate, sensitive, and reproducible approach that can measure the amount of drug present in the skin at different depths below the surface. This approach will be used to monitor the cutaneous pharmacokinetics (PK) of the drug over time. The ultimate aim is to develop a scientifically valid in vivo cutaneous PK-based approach that can efficiently demonstrate the bioequivalence (BE) of topical products.

The funding opportunity has an award ceiling of $250,000 and an estimated total program funding of $250,000. It is expected that one award will be granted. The opportunity will close on April 8, 2024, and the archive date is set for April 30, 2024. For more information, you can visit the following link: RFA-FD-24-008 Funding Opportunity Announcement.

For any further inquiries, you can contact Terrin Brown, the grantor, at terrin.brown@fda.hhs.gov.

Point(s) of Contact
Files
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