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

About this grant

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 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 expectation is that the funded work will produce an accurate, sensitive and repr Grant Number: FOR-FD-24-004. Expected awards: 1.

Eligibility requirements

All of the following criteria must be met:

• 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 statemen

What the funding covers

• Award Range: $250K to $250K
• Expected Number of Awards: 1

How to apply

1. 1Check eligibility: Confirm your organization type (e.g., nonprofit, state government), project alignment, and deadlines from the opportunity synopsis.
2. 2Register: Create a Grants.gov account via Login.gov, complete SAM.gov and UEI registration, and authorize organization representatives (takes 2-4 weeks).
3. 3Prepare application: Select "Apply" to open Workspace, download forms (e.g., SF-424), complete offline/online with validation checks, and upload supporting docs like budgets and narratives.
4. 4Submit and track: Check package for errors, sign/submit via Authorized Organization Representative (AOR), and monitor status with your tracking number
5. 5Applications must be submitted through grants.gov
6. 6Grant Number: FOR-FD-24-004
7. 7Posted: 2023-11-24

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