FDA publishes revised draft guidance for developing direct-acting antiviral drugs for treatment of chronic hep C

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA publishes revised draft guidance for developing direct-acting antiviral drugs for treatment of chronic hep C

Information about FDA Hepatitis product approvals, safety warnings, medical product labeling changes, notices of upcoming public meetings, and notices about proposed regulatory guidances.

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FDA has revised a draft guidance, titled Chronic Hepatitis C Virus Infection:  Developing Direct-Acting Antiviral Drugs for Treatment. 

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.

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

For more information about the Hepatitis Liaison Program visit the FDA Patient Network

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