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Labeling

BREAKING NEWS: FDA Denies Citizen Petitions Regarding Biosimilar Labeling

Biosimilar News  •  BPCIA and Related U.S. Statutes  •  FDA Citizen Petition Tracker  •  Labeling
FDA denied citizen’s petitions from Abbvie, the UAW Retiree Medical Benefits Trust, and the Pharmaceutical Research and Manufacturers of America (“PhRMA”) and Biotechnology Industry Organization (“BIO”) trade associations requesting that FDA impose particular labeling requirements on biosimilar applicants.  […]

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