The “N” in Pain is Silent: One Company's Approach to FDA Prenda Approval Inspections

Abstract

The advent of pre-New Drug Application (NDA) approval inspections in the early 1990s was not anticipated by the pharmaceutical industry. Thus, it is not surprising that the industry as a whole was not well prepared for these inspections. This is evidenced by the high turndown rate in the early years of the inspection program. The sudden advent of these inspections, coupled with the unclear Food and Drug Administration (FDA) standards that existed at the time the program was initiated, caused many companies with pending applications a great deal of concern. The first several pre-NDA approval inspections were a painful experience for all those involved in preparing for them. As FDA defined and communicated its standards, pharmaceutical companies established internal business processes to address these inspections; the pain associated with these inspections decreased significantly. This is supported by the observation that the FDA turndown rate has decreased to approximately 30% in recent years. This article describes the internal business process that one research-based company put in place to respond to the FDA's pre-NDA approval inspection program. The benefits derived from these internal efforts are described.