Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention.'' The purpose of this guidance is to assist sponsors in all phases of development of treatments for recurrent herpes labialis (RHL). The guidance also addresses prevention of RHL. The guidance outlines the types of nonclinical studies and clinical trials recommended throughout the drug development process to support approval of antiviral drug products for the treatment or prevention of RHL. This guidance finalizes the draft guidance of the same name issued on July 1, 2016.