Issue Date: May 15, 1998
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Final
Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.
This document is intended to provide guidance to applicants planning to file new drug applications (NDAs), biologics license applications (BLAs), or applications for supplemental indications on the evidence to be provided to demonstrate effectiveness.
Download the Guidance Document
