Chapter 17 – Regulatory Considerations

This chapter highlights regulatory mechanisms governing the development of neuroemergency products and assesses the regulatory climate around these processes. Neuroemergency regulatory strategies can be gleaned from procedures associated with the development of serious conditions, which serve as a useful framework for the design and implementation of successful neuroemergency programs. Strategies for sponsors considering the development of such programs include clearly defining prospective goals, projecting product labeling, and identifying regulatory strategies to support these objectives. The importance of close and early dialogue with the US Food and Drug Administration (FDA) within the context of mechanisms, such as pre-Investigational New Drug meetings, is also discussed. Mechanisms such as Fast Track Designation, Accelerated Approval, Breakthrough Therapy, Priority Review, and Special Protocol Assessment are presented as ways to benefit the development of neuroemergency drug products and enable constructive collaboration with the FDA.