Federal Register Notice: FDA is making available a guidance for industry entitled Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency to assist sponsors in developing and submitting nonclinical and clinical virology data important to support clinical trials of antiviral products. Topics included in the document are studies 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, and providing data that identify cross-resistance to approved products having the same target. The guidance finalizes a draft guidance announced 5/25/05. To download this guidance, click here. To view this notice, click here.