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GUIDANCE DOCUMENT

Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency June 2006

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2005-D-0282
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to assist sponsors in the development of antiviral drugs and biological products (i.e., therapeutic proteins and monoclonal antibodies) from the initial preIND through the new drug application (NDA) and postmarketing stages. This guidance should serve as a starting point for understanding what nonclinical and clinical virology data are important to support the submission of an investigational new drug application (IND), NDA, or biologics license application (BLA) for approval of an antiviral product. This guidance focuses on nonclinical and clinical virology study reports and makes recommendations for collecting and submitting resistance data to the Food and Drug Administration (FDA). Nonclinical and clinical virology study reports, based on collected data, are essential for the FDA’s review of antiviral drug investigational and marketing applications.

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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-2005-D-0282.

 
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