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# FDA Posts Draft Guide on Hep C Drug Development
- URL: https://www.fdaweb.com/fda-posts-draft-guide-on-hep-c-drug-development/
- Published: 2016-05-03T12:00:00.000Z
- Updated: 2026-09-14T20:58:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135558

> FDA has posted a [draft guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM225333.pdf?ref=fdaweb.com) on “Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral (DAA) Drugs for Treatment” that offers recommendations on the overall development program and clinical trial designs to support such drugs. The document is intended to serve as a focus for continued discussions among the Division of Antiviral Products, pharmaceutical sponsors, the academic community, and the public. It does not address the development of drugs that target host functions necessary for viral replication or immune-based drugs for the treatment of HCV infection such as new interferon (IFN) drugs, it says. “The main focus of this guidance is on development of DAAs as part of IFN-free regimens,” it says. Additionally, general issues of statistical analyses or clinical trial design are not addressed in the guidance.