FDA Pushes Back Comment Period for Biosimilar Labeling

June 9, 2016

The FDA is extending the comment period for its draft guidance on labeling for biosimilars by 60 days to Aug. 2.

The agency had asked for feedback from industry in April on the guidance, which recommends that biosimilars sponsors put information from the reference product labeling on the labeling for the biosimilar product.

Interested parties can submit comments here: https://www.regulations.gov/#!documentDetail;D=FDA-2016-D-0643-0001.

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