On the Verb Tense to be Used in the Investigator's Brochure

Abstract

Food and Drug Administration (FDA) regulations pertaining to preparation of an Investigator’s Brochure (IB) emphasize that the IB should summarize preclinical and clinical effects of the drug substance, and not that experiments should be archived in detail. The proper verb tense for presenting summarized effects believed by sponsors to characterize the effects of a new drug is the present. For example, sponsors should summarize results from their supportive animal safety studies in the IB by asserting which effects are or arc not present in the species under test, and not which were or