Draft Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis; Request for Comments

摘要

The Food and Drug Administration (FDA) is requesting comments on a draft guidance entitled "Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis." The guidance was issued in 1994 (1994 draft guidance). During the past decade, a significant body of data related to the diagnosis, prevention, and treatment of osteoporosis has been published. Much of this information is relevant to osteoporosis drug development and, in particular, relates to issues surrounding clinical trial design and duration. The agency is preparing to develop an updated draft guidance on the same topic and is seeking comment on the 1994 draft guidance.