Orphan Products Board: Annual Reports 1988 and 1989

摘要

The document combines the sixth and seventh annual reports on the status of orphan product development as coordinated within the Department of Health and Human Services (DHHS) by the Orphan Products Board (OPB). The Orphan Drug Act established the Orphan Products Board. The Board is chaired by the Assistant Secretary for Health (ASH). It includes representatives from the Food and Drug Administration (FDA), the National Institutes for Health (NIH), and the Centers for Disease Control (CDC) as well as '...any other Federal department or agency which the Secretary determines has activities relating to drugs and devices for rare diseases or conditions.' The 'function of the Board shall be to promote the development of drugs and devices for rare diseases or conditions and the coordination among Federal, other public, and private agencies in carrying out their respective functions relating to the development of such articles for such diseases or conditions.' The activities of the individual agencies during 1988 and 1989 are reported.