Zdrowie i gospodarka · 13/03/2001

Acceptance of Foreign Clinical Studies; Availability

The Food and Drug Administration (FDA) is announcing the availability of a final guidance entitled "Acceptance of Foreign Clinical Studies." This final guidance is intended to clarify the ethical principles with which a sponsor must comply before FDA would accept a foreign clinical study not conducted under an investigational new drug application (IND) or investigational device exemption (IDE) in support of a marketing approval application.