Issue Date: April 13, 2011
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Final
Influenza: Developing Drugs for Treatment and/or Prophylaxis
The purpose of this guidance is to assist sponsors in the development of drugs for the treatment and/or prophylaxis of illness caused by influenza viruses A and B, including both seasonal and pandemic varieties. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and designs of clinical trials and nonclinical studies to support the development of influenza drug products.
Download the Guidance Document
