April 15, 2005
The Food and Drug Administration (FDA) released the draft guidance document, "Guidance for Industry, Investigators and Reviewers: Exploratory IND Studies," announced by the Federal Register on April 14, 2005 (download the draft guidance in the related items box below). SNM is currently preparing written comments regarding the draft guidance document.
The draft document notes that, depending on the study, the preclinical testing programs for exploratory IND studies "can be less detailed and more flexible than for traditional IND studies." In addition, the document clarifies what preclinical and clinical approaches (including chemistry, manufacturing and controls) should be considered when planning exploratory IND studies in humans, including studies of closely related drugs or therapeutic biological products under an investigational new drug application (21 CFR 312).