Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV-1 Resistance Data: Attachment to the Guidance: Draft Draft Guidance: This draft guidance updates the final guidance posted 6/2/06

Issue Date: February 28, 2014
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Draft

Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV-1 Resistance Data: Attachment to the Guidance: Draft Draft Guidance: This draft guidance updates the final guidance posted 6/2/06

Sponsors are encouraged to use the following sample format for submitting HIV-1 resistance data.

Download the Guidance Document