Docket Number:
FDA-2019-D-5473
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance addresses questions firms may have when developing FDA-regulated promotional labeling and advertisements (promotional materials) , for prescription reference products licensed under 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a))

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All written comments should be identified with this document's docket number: FDA-2019-D-5473.