Issue Date: February 12, 2001
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Final
Clinical Development and Labeling of Anti-Infective Drug Products
Changing or unclear interpretations of clinical trail data needed to demonstrate the effectiveness and safety of anitmicrobial drug products have at times lead to confusion and frustration on the part of both applicants and Division of Anti-Infective Drug Products reviewers.
Download the Guidance Document
