Human Subject Protection - Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application - Final Rule (US Food and Drug Adminis

Human Subject Protection - Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application - Final Rule (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Human Subject Protection - Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application - Final Rule (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA) is amending its regulations on acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) (non-IND foreign clinical studies) as support for an IND or application for marketing approval for a drug or biological product. The final rule replaces the requirement that these studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki (Declaration) issued by the World Medical Association (WMA), specifically the 1989 version (1989 Declaration), with a requirement that the studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC). The final rule updates the standards for the acceptance of foreign clinical studies not conducted under an IND and helps ensure the protection of human subjects and the quality and integrity of data obtained from these studies. This book contains: - The complete text of the Human Subject Protection - Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application - Final Rule (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section