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Nonproprietary Naming of Biological Products Guidance for ...

Nonproprietary Naming of Biological Products Guidance for Industry Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) January 2017 Labeling OMB control number XXXX-XXXX Expiration Date: xx/xx/xxxx The information collection provisions in this Guidance regarding submission of proposed suffixes are under OMB review and are not for current implementation. See additional PRA statement in section VII of this Guidance . Nonproprietary Naming of Biological Products Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave.

This naming convention will facilitate pharmacovigilance for originator biological products, related biological products, and biosimilar products containing related drug substances when

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  Product, Biological, Naming, Convention, Nonproprietary, Naming conventions, Nonproprietary naming of biological products

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