A Road Map To Expedited Review Pathways
Overview
For many years, accelerated development and manufacturing timelines have provided 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 U.S. FDA, EU EMA, Health Canada, Japan PMDA, Chinese NMPA, and Brazilian ANVISA, offer expedited approval pathways that are applicable when new products are filling unmet medical needs for certain targeted diseases or conditions
Learn more about how Quotient Sciences helps customers navigate the development pathway, meeting the regulatory requirements of a product granted expedited development and review, as well as generating data needed to support drug approval.