Issue Date: June 5, 2006
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Final
Antiviral Product Development–Conducting and Submitting Virology Studies to the Agency
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.
Download the Guidance Document
