A Look Ahead Toward Possible Future Analytical Requirements by FDA

Abstract

Even the most venturesome clairvoyants, with their heads in the clouds and their gaze fixed on futurity, must stand firmly on the ground of the present; and therefore they generally open their dark parable on the shape of things to come with a recitation depicting the status of things as they are, as accurately as circumstances permit. In that tradition, I take as my point of departure a brief exposition on the current analytical requirements of FDA before embarking on my personal prognostication foreshadowing the lineaments toward which future requirements might evolve. Please note at the outset my emphasis on the first person singular, and the disclaimer such usage implies. The prophecies I offer on this program are my own, and do not necessarily adumbrate the developing attitudes and actions of the sponsor.