More Similarities than Differences

Abstract

Experience with the Food and Drug Administration (FDA) suggests that many similarities exist among the various divisions that review investigational new drug (IND) and new drug applications (NDA) with respect to aims and requirements for preparation for major FDA-industry conferences. A series of questions were posed to FDA managers to permit compilation of information pertinent to this hypothesis. The following conclusions can be drawn. Pre-IND conferences are appropriate for entirely novel, important lines of research or when data obtained from foreign studies or sources external to the applicant are to be used to support entry into more advanced phases of clinical research. Conferences on major clinical protocols are desirable for studies that are novel, controversial, or highly resource intensive. End-of-Phase II conferences should focus on specific issues for which FDA input is desired. End-of-Phase III conferences should be concerned primarily with format for NDA data presentation. Advisory committee presentations by industry are expected to be thorough and balanced.