Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

For Consumers

Final Guidance for Industry on Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency

FDA published, this week, a final Guidance for Industry on Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency  to assist sponsors in the development of antiviral drugs and biological products (i.e., therapeutic proteins and monoclonal antibodies) from the initial pre-IND through the new drug application (NDA) and postmarketing stages.

The guidance serves 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), New Drug Application (NDA), or Biologics License Application (BLA) for approval of an antiviral product. The 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 FDA's review of antiviral drug investigational and marketing applications. Specific topics discussed in the guidance include:

  • Defining the mechanism of action
  • Establishing specific antiviral activity of the investigational product
  • Assessing the potential for antagonism of other antiviral products that might be used in combination with the investigational product
  • Providing data on the development of viral resistance to the investigational product
  • Providing data that identify cross-resistance to approved antiviral products having the same target

The guidance document, and specific topic attachments are available on the FDA web site through the following links:

The Guidance

The Guidance Attachment -Submitting HIV Resistance Data
The Guidance Attachment- Submitting Influenza Resistance Data
The Guidance Attachment- Submitting HBV Resistance Data
The Guidance Attachment- Submitting HCV Resistance Data

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

Page Last Updated: 08/05/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.