OpportunityTitle: Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed)
AdditionalInformationOnEligibility: Higher Education Institutions&#8226; Public/State Controlled Institutions of Higher Education &#8226; Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutionso Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher Education&#8226; Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) &#8226; Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations&#8226; Small Businesses&#8226; For-Profit Organizations (Other than Small Businesses)Governments&#8226; State Governments &#8226; County Governments&#8226; City or Township Governments&#8226; Special District Governments&#8226; Indian/Native American Tribal Governments (Federally Recognized) &#8226; Indian/Native American Tribal Governments (Other than Federally Recognized)&#8226; U.S. Territory or PossessionOther&#8226; Independent School Districts&#8226; Public Housing Authorities/Indian Housing Authorities&#8226; Native American Tribal Organizations (other than Federally recognized tribal governments)&#8226; Faith-based or Community-based Organizations&#8226; Regional Organizations&#8226; Non-domestic (non-U.S.) Entities (Foreign Institutions)
Description: The purpose of this funding opportunity is to support the research and development necessary to elucidate specific considerations that may be uniquely relevant to evaluating the bioequivalence (BE) of ungual (nail), scalp, vaginal, or rectal topical drug products. A specific emphasis of this funding opportunity involves the development of in vitro or ex vivo, comparative product characterization-based BE approaches.
GrantorContactEmailDescription: Work Email
GrantorContactText: Shashi Malhotra &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 2404027592