ABSTRACT
As other contributors to this volume demonstrate, blood substitutes present spe cial challenges to investigators. I would like to discuss the unique problems they present to regulatory authorities. The U.S. Food and Drug Administration (FDA) has been involved with review of blood substitute data, and with the associated problems, for almost twenty years. This review presents a brief de scription of the FDA’s organization, an overview of the review process, a re counting of the history of the FDA’s experience with blood substitutes, and a discussion of the FDA’s perspective on some specific aspects of the review of blood substitutes. It attempts to show how these are unique and to make com parisons with other biological products. Finally, some of the actions taken by the FDA to expedite the development process are presented.
