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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.