Docket Number:
FDA-2018-D-1895
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 drafting the INDICATIONS AND USAGE section of labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products2  (21 CFR 201.57(c)(2)).
 

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All written comments should be identified with this document's docket number: FDA-2018-D-1895.