Antiviral Product Development–Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HCV Resistance Data

Issue Date: June 2, 2006
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Final

Antiviral Product Development–Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HCV Resistance Data

Sponsors are encouraged to use the following sample format for submitting HCV resistance data.

Download the Guidance Document

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