White Paper

Accelerating Regulatory Approval For Drugs And Biologics In The US

Source: Rho
white paper image

The FDA has created four different methods to help speed up the approval of drugs and biologics that can treat serious diseases – Accelerated Approval (AA), Breakthrough Therapy Designation (BTD), Fast Track Designation (FTD), and Priority Review (PR).  This white paper provides an overview of these four mechanisms and will help you to understand the requirements and benefits of each. Download it in order to make a more informed decision about what’s possible or what’s best for your drug development program.