Department of Health and Human Services April 14, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is declaring unlawful the unapproved marketing of certain parenteral multivitamin drug products for which a hearing was requested, but for which the sponsors have withdrawn the hearing requests. FDA is taking this action because the products lack substantial evidence of effectiveness as fixed combination drug products.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Exploratory IND Studies.'' This draft guidance clarifies what preclinical and clinical issues (including chemistry, manufacturing, and controls issues) should be considered when planning exploratory studies in humans, including studies of closely related drugs or biologics, under an investigational new drug (IND) application. This draft guidance emphasizes the concept that limited investigations in humans can be initiated with more limited preclinical support because such studies present fewer potential risks than do traditional phase 1 studies that look for dose-limiting toxicities.