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FDA Extends Comment Period for Biosimilar Labeling Guidance

July 18, 2016

Due to high levels of interest and feedback, the FDA is extending the comment period for the much anticipated draft guidance “Labeling for Biosimilar Products; Draft Guidance for Industry; Availability” that was first released on April 4, 2016. The Agency is now accepting comments through August 2, 2016

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The Center for Biologic Policy Evaluation

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