Docket Number:
FDA-2017-D-6969
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance is intended to assist applicants in complying with certain labeling requirements for human prescription drug and biological products (21 CFR 201.56 and 201.57).

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All written comments should be identified with this document's docket number: FDA-2017-D-6969.