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The Cancer Letter Inc.
PO Box 9905
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Tel: 202-362-1809
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publication date: Apr 1, 2016
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Drugs and Targets

FDA Publishes Draft Guidance On Biosimilar Product Labeling 

 

FDA published a draft guidance of recommendations for biosimilar product labeling.

Based on a demonstration of biosimilarity, biosimilar product labeling should include a description of the clinical data that supported safety and efficacy of the reference product as described in the FDA-approved product labeling for the reference product, the agency said.



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