FDA Orphan Product Grants
This article was originally published in The Gray Sheet
Executive Summary
FDA's Office of Orphan Products Development is soliciting sponsors of "clinical studies on medical devices for rare diseases or conditions." Applications for grants are due by either Jan. 15 or Oct. 1, 1995. The OPD grants are to be used for clinical studies, the office says, and are "intended to provide data required and acceptable to FDA in the review of" 510(k) and premarket approval applications. All studies must be conducted under an investigational device exemption or an investigational new drug application