Labeling

FDA Has Extended the Comment Period For Its Draft Biosimilar Labeling Guidance

The FDA has extended the public comment period for its draft guidance “Labeling for Biosimilar Products: Guidance for Industry” by 60 days, to August 2, 2016: https://www.federalregister.gov/articles/2016/06/06/2016-13223/labeling-for-biosimilar-products-draft-guidance-for-industry-availability-extension-of-comment

On September 17, 2015, Janet Woodcock, M.D., the director of the FDA’s Center for Drug Evaluation and Research, testified at a congressional hearing on the topic of biosimilars. A link to her written testimony is provided here, and a link to the video of the Q&A session is provided here….

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Tagged as: Labeling

FDA Has Extended the Comment Period For Its Draft Biosimilar Labeling Guidance

Director of CDER Fields Senate Questions on Biosimilars