The Impact of Breakthrough Therapy Designation on Development Strategies and Timelines for Nononcology Drugs and Vaccines

Clin Pharmacol Ther. 2016 Dec;100(6):603-605. doi: 10.1002/cpt.447. Epub 2016 Sep 23.

Abstract

The US Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA, 2012) introduced the Breakthrough Therapy Designation (BTD), a new tool to expedite development of medicines to treat serious or life-threatening diseases. The majority of BTDs have gone to oncology drugs, and a recent publication by Shea et al.1 reviewed the impact of BTD on oncology drug development. This article reviews the impact of BTD on development strategies and timelines for nononcology drugs.

MeSH terms

  • Drug Approval / legislation & jurisprudence*
  • Drug Design*
  • Humans
  • Pharmaceutical Preparations / administration & dosage*
  • Time Factors
  • United States
  • United States Food and Drug Administration
  • Vaccines / administration & dosage*

Substances

  • Pharmaceutical Preparations
  • Vaccines