Sponsor Deadline
Posted: 4/18/2022

FDA -- Enhancing Regulatory Science for Advancing Pharmaceutical Quality and Manufacturing (U01) Clinical Trials Optional

The goal of this program is to support the advancement of regulatory science that can (1) facilitate the implementation and the assessment of emerging manufacturing technology in the pharmaceutical sector; (2) expand the knowledge base related to complex products and formulation development, analysis, and manufacturing control to advance risk-based quality assessment of new and generic drug products.      


  • Letter of Intent Due Date(s): February 28, 2020 for April 10, 2020 application due date. For all subsequent application due dates, letter of intent will be due 60 days prior to the application due date.
  • Application Due Date(s)

    April 10, 2020, by 11:59 PM Eastern Time.

    April 5, 2021, by 11:59 PM Eastern Time.

    April 4, 2022, by 11:59 PM Eastern Time.

PAR-20-083 Expiration Date April 11, 2022

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: $1,000,000
YR 02: $1,000,000
YR 03: $1,000,000

YR 04: $1,000,000

YR 05: $1,000,000

Funding Type