The evolution of FDA's role in ensuring product quality uri icon

abstract

  • The quality of a drug product is an essential element of drug safety and efficacy. With a statutory mission to provide safe and effective medications to the public, the US Food and Drug Administration has always focused on drug quality. The authors summarize the history of FDA's role in ensuring product quality and its role in shaping risk-based approaches to this goal.

published proceedings

  • Pharmaceutical Technology

author list (cited authors)

  • Shah, R. B., & Khan, M. A.

complete list of authors

  • Shah, RB||Khan, MA

publication date

  • July 2007