By: Frank Casty, Senior Clinical Regulatory Advisor, NDA Group
In this great article published in the September issue of Pharmafocus, Frank Casty discusses “Expedited Reviews: What you need to know to be successful”
Speed to market is a critical component of any drug development strategy – not only from a commercial standpoint, but also for patients awaiting better treatment options. Throughout the drug development process there are many factors influencing speed to market but none more visible and critical than an expedited regulatory review.
The debate around how regulators can facilitate this process on both sides of the Atlantic has been top of mind for decades. During the early 1980s public outrage focused the FDA on faster reviews of HIV/AIDS treatments. In 2012, the FDA Safety and Innovation Act which introduced Breakthrough Therapy Designation, was followed by a final guidance in 2014 describing requirements for the four main expedited pathways, Fast Track(1), Breakthrough Therapy Designation (2), Accelerated Approval(3) and Priority Review(4).
In 2016, the Regenerative Medicines Advanced Therapy Designation, designed for expedited reviews of certain biologics, came about because of the 21st Century Cures Act. Recently, another expedited review process for antibacterial and antifungal agents, the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) has been established.
At NDA, we support many companies in both the US and Europe seeking multiple expedited review procedures. We will be discussing this in more detail in our upcoming webinar, where we will be ready to answer any questions you may have.