Bringing Information on Evolving FDA Standards to Bear on Ongoing Drug Development Programs

Abstract

The process of drug development and the introduction of a new product to the marketplace can be viewed as a regulatory exercise. The regulatory affairs professional, by virtue of her/his understanding of regulatory agency standards and requirements, has, perhaps more than anyone else involved in drug development, the opportunity to add substantial value to the overall process of developing a new product. In as much as regulatory agency expectations and requirements are continually evolving, it is incumbent on the regulatory affairs professional to continually and aggressively monitor the regulatory environment in order to identify relevant items which may impact drug development. The regulatory environment which must be monitored goes far beyond the law, the implementing regulations, or regulatory agency-issued guidelines. The scope of the regulatory environment is so broad that gathering regulatory intelligence requires a significant amount of time and effort. Information on evolving regulatory agency standards and requirements is, however, of little value unless reliable and effective mechanisms are in place within the corporation to evaluate and react to such input in a timely way. Multidisciplinary project teams, managed and driven by an effective project leader, are ideally suited for this purpose and are widely used by the industry. The value in bringing evolving Food and Drug Administration (FDA) standards to bear on the drug development process can be measured in reduced time-to-market, reduced costs of development, and optimization of the market potential of new products.