Issue Date: October 8, 2015
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural
Status: Final
Integrated Summary of Effectiveness
This guidance describes the recommended content of the integrated summary of effectiveness (ISE) for inclusion in a new drug application (NDA) or biologics license application (BLA).2 Although there are no regulations requiring an ISE for BLA submissions, applicants are encouraged to provide an ISE because it represents an opportunity to present a coherent analysis and presentation of the drug’s benefits.
Download the Guidance Document
