Issue Date: April 21, 2009
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural
Status: Final
Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document
This guidance is intended to clarify for industry where to include the integrated summary of effectiveness (ISE) and integrated summary of safety (ISS) when submitting applications in the common technical document (CTD) format. The guidance applies to applicants submitting new drug applications (NDAs) or biologics license applications (BLAs) to the Food and Drug Administration (FDA) in the CTD or the electronic common technical document (eCTD) format.
Download the Guidance Document
