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

Funding Agency:
National Institutes of Health

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.


  • Letter of Intent Due Date(s): February 25, 2019
  • Application Due Date(s): April 11, 2019

​RFA-FD-19-008 Expiration Date April 12, 2019

Agency Website



Amount Description

Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

YR 01: $250,000

YR 02: $250,000

Funding Type





Medical - Basic Science
Medical - Clinical Science
Medical - Translational

External Deadline

April 11, 2019