Post-marketing surveillance, annual reports and long term follow-up.

Abstract

This conference has taken us from the early phases of drug development to the NDA, and this session dcals with issues that are critical in the final stages of NDA submission, and afterward. Dr. Borden and I will discuss post-marketing issues specifically. In chorus with the speakers earlier in the meeting, I contend that thinking of the post-marketing, or Phase IV stage of a drug should be part of the earlier planning in drug development. To that end, Figure 1 is a conceptual diagram of the accrual of the "volume" of knowledge of a drug during its phases of development. Although the volume increases, the knowledge about a drug is still incomplete at the time of NDA approval-the degree of incompleteness being somewhat dependent upon the newness of the molecular entity. With respect to adverse effects, the concept has been that studies and information acaued soon after approval [so called early post-marketing surveillance (PMS)] would round out the information gaps. Ideally,