FDA Pushes Back Comment Period on Hep C Drug Development Guidance

June 30, 2016

The FDA has extended the comment period for its draft guidance for developing direct-acting antiviral hepatitis C drugs to July 19.

The agency attributes the extension to maintenance on the Federal eRulemaking portal from July 1 through July 5.

The draft guidance, which recommended that companies factor in interferon treatment when designing clinical trials, previously was released for comment in May.

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