Cardinal Health Specialty Solutions

Expediting drug approval

Speed your time to market with FDA’s expedited programs

Your trusted partner for navigating regulatory pathways

Whether you’re seeking fast track designation, breakthrough therapy designation, accelerated approval pathway or priority review designation, Cardinal Health Specialty Solutions can provide the guidance needed to help you realize the full benefits of these programs and reduce your drug development timeline.

In this article:

  • How expedited programs work
  • Overview of the four FDA expedited programs
  • Best practices for navigating an expedited pathway

Effectively Navigating FDA Expedited Programs

Todd Phillips, Principal Scientist with Cardinal Health Regulatory Sciences, provides advice on steps biopharma companies should take when considering an FDA expedited pathway.