Supporting the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional

Archived

Food and Drug Administration

Description

The purpose of this Funding Opportunity Announcement (FOA) is to address topics related to FDA's Real-World Evidence (RWE) Program and to enable FDA to assess the potential utility of real-world data (RWD) in generating RWE.

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
  • PostedDec 13, 2022
  • ClosesFeb 28, 2023
  • Award floor$1,000,000
  • Award ceiling$6,750,000
  • Program funding$7,000,000
  • CFDA93.103

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