Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.
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Food and Drug Administration - June 8, 2006
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:
The guidance document, and specific topic attachments are available through the following links:
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
060608SOURCE: Food and Drug Administration (FDA).
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