Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed)

Archived

Food and Drug Administration

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.

Who can apply

  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • 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)
  • Nonprofits with 501(c)(3) status (other than higher education)
  • Nonprofits without 501(c)(3) status (other than higher education)
  • Private institutions of higher education
  • For-profit organizations other than small businesses
  • Small businesses
  • Others

Contact

Shashi Malhotra <br/>Grants Management Specialist <br/>Phone 2404027592
shashi.malhotra@fda.hhs.gov

Key dates & funding
  • PostedFeb 7, 2019
  • ClosesApr 11, 2019
  • Award floor$250,000
  • Award ceiling$500,000
  • Expected awards1
  • CFDA93.103

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