Post-market Surveillance of Generic Modified Release Products (U01)

Archived

Food and Drug Administration

Description

The purpose of this study is to analyze use, substitution patterns, safety and effectiveness of generic modified release products, and compare them with their respective brand name drug products and other generic drugs with different formulation design characteristics. The outcome(s) of this study will help determine if there are differences in the patterns of use, substitution, and safety and effectiveness associated with the studied generic modified release products, and to provide further evidence regarding their substitutability for brand name drugs.

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

Lisa Ko <br/>Grants Management Specialist <br/>
lisa.ko@fda.hhs.gov

Key dates & funding
  • PostedApr 20, 2015
  • ClosesJun 29, 2015
  • Award ceiling$500,000
  • Program funding$500,000
  • Expected awards1
  • CFDA93.103

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