Approaches to attenuated psychosis syndrome treatments: A perspective on the regulatory issues

摘要

The task of researching and developing novel therapeutic agents, especially in the therapeutic area of central nervous system (CNS) drugs, remains an expensive, uncertain, time-consuming, competitive, and inefficient enterprise (Safavi et al., 2016). These challenges result in a very high failure rate of CNS drug development programs and pose continuous challenges for all stakeholders involved in drug discovery, including regulators and payers alike.