US FDA’s Biosimilars Group Will Conduct Some Supplement Reviews, Become ‘Like Another Discipline’

Office of Therapeutic Biologics and Biosimilars Director Sarah Yim says in an interview with the Pink Sheet that more staff are being added to deal with labeling supplements.

division of labor
Signatory authority will remain with the review division, but OTBB staff will perform a primary review of some biosimilar labeling supplements. • Source: Shutterstock

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