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Influenza: Developing Drugs for Treatment and/or Prophylaxis April 2011

Docket Number:
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research

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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0044 .