Guidance for Industry on Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document." Since FDA began accepting new drug application (NDA) and biologics license application (BLA) submissions in the common technical document (CTD) format, there has been confusion regarding where within the CTD to include an integrated summary of effectiveness (ISE) and integrated summary of safety (ISS), both of which are required components of an NDA submission and recommended components of a BLA submission. This guidance informs applicants where to place the ISE and ISS in the CTD, addresses specific FDA requirements not discussed in the ICH guidance for industry "M4E: The CTD--Efficacy," and is intended to improve application quality and consistency. This guidance finalizes the draft guidance of the same title published in the Federal Register of July 3, 2007 (72 FR 36471).