Time to Revisit a Voluntary FDA Comparative Effectiveness Pathway

Research output: Contribution to journalComment/debatepeer-review


Given the renewed policy focus on drug pricing and pharmaceutical innovation, this article examines the historical backdrop of efforts to integrate comparative effectiveness research into the FDA drug review process. Noting previous policy efforts over a decade ago, we characterize industry challenges and suggest a path forward.

Original languageEnglish (US)
JournalTherapeutic Innovation and Regulatory Science
StateAccepted/In press - 2021


  • Comparative effectiveness research
  • FDA regulation
  • Innovation
  • Real world evidence

ASJC Scopus subject areas

  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
  • Public Health, Environmental and Occupational Health
  • Pharmacology (medical)

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