Market Exclusivity and Changes in Competition and Prices Associated With the US Food and Drug Administration Unapproved Drug Initiative

JAMA Intern Med. 2021 Aug 1;181(8):1124-1126. doi: 10.1001/jamainternmed.2021.1989.

Abstract

This cohort study assesses the long-term associations of the US Food and Drug Administration Unapproved Drug Initiative with market exclusivity characteristics and price changes.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Drug Approval* / methods
  • Drug Approval* / organization & administration
  • Drug Costs / legislation & jurisprudence
  • Drug Industry* / economics
  • Drug Industry* / legislation & jurisprudence
  • Drugs, Generic / economics
  • Economic Competition*
  • Humans
  • Orphan Drug Production
  • United States

Substances

  • Drugs, Generic