A Roadmap To Expedited Review Pathways

Accelerated development and manufacturing timelines provide developers with paths to move new therapies to market quickly while still maintaining a balance of risk/benefit assessment for patients. Regulatory agencies around the world, including the US FDA, EU EMA, Health Canada, Japan PMDA, Chinese NMPA, and Brazilian ANVISA offer expedited approval pathways that are applicable when certain criteria are met by the product and the targeted disease or condition.

In the U.S., key differentiators between the Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval designations include the program requirements and their allowances in terms of agency guidance, review process, approval time and/or use of surrogate clinical endpoints for supporting clinical benefit. These designations can occasionally be stacked, with programs often having multiple designations.

As new technologies, unpredictable geopolitical occurrences, and increasing demand for services add to the burdens of drug development and manufacture, it is imperative that sponsors maximize operational efficiency and minimize associated risk. A key way to accomplish this is by taking advantage of expedited approval pathways, and an experienced CDMO partner can light the path.