Regulatory Strategy: A Blueprint for Drug Development

Abstract

An efficient drug development process, and rapid review and approval are the goals of every pharmaceutical sponsor, but numerous factors make this goal difficult and sometimes impossible to achieve. Although some of these factors are beyond the control of the sponsor, many delays in the regulatory process can be avoided by conceiving a regulatory strategy early in the development process. This paper describes a regulatory strategy document that serves as a blueprint for the development of drugs within a particular class. This document draws from a variety of regulatory information sources with the goal of identifying key issues that must be addressed in order to demonstrate safety and efficacy and gain Food and Drug Administration (FDA) approval for a drug. When a regulatory strategy document is prepared prior to development planning and updated throughout the development process, it provides the project team with a valuable reference resource and guideline, enabling them to make informed decisions in line with FDA requirements. This will ultimately reduce avoidable delays in the development, review, and approval processes and allow for the marketing of important new drugs.