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FDA Issues Revised Draft Guidance on Developing New Hep C Treatments

FDA has revised a draft guidance, titled Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment. [PDF 665 KB]

The purpose of the guidance is to assist sponsors in the clinical development of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C (CHC) from the pre-investigational new drug application (pre-IND) through the new drug application (NDA) and postmarketing stages.

FDA defines direct-acting hepatitis C virus (HCV) antivirals as drugs that interfere with specific steps in the HCV replication cycle through a direct interaction with the HCV genome, polyprotein, or its polyprotein cleavage products.

The guidance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs to support DAA drugs.

The guidance is available on the FDA website. [PDF 665 KB]