Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for

Guidance for Industry
Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for
Treatment
DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document contact Jeffrey Murray at (301) 796-1500.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
September 2010
Clinical Antimicrobial

open here to see the full-text:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM225333.pdf