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

In plain English

Food and Drug Administration (Department of Health and Human Services) has announced this as a forecast: an opportunity it expects to post. It is not open for applications yet.

Awards are up to $250,000 each and the agency expects to make 1 award.

Eligibility is listed as unrestricted (open to any type of applicant), subject to any clarification in the listing.

The listing says cost sharing or matching is not required.

Built only from the fields in the Grants.gov listing. Always confirm on the official listing.

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• State governments
• County governments
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• Special district governments
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• Public and state-controlled institutions of higher education
• Native American tribal governments (federally recognized)
• Public housing authorities / Indian housing authorities
• Native American tribal organizations (other than federally recognized tribal governments)
• Nonprofits with 501(c)(3) status (other than institutions of higher education)
• Nonprofits without 501(c)(3) status (other than institutions of higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others (see the eligibility details in the listing)
• Unrestricted (open to any type of entity above, subject to clarification in the listing)

Additional eligibility information (excerpt from the listing):

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 resubmission (A1) application that is submitted before issuance of the summary statement from the review of the …

Excerpt from the official forecast on Grants.gov (shortened; read the full text on the official listing):

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 reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis) by repeated, serial measurements over time. …

Read the full forecast on Grants.gov →