Docket Number:
FDA-2014-D-1551
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 the content and format requirements for the Pregnancy, Lactation, and Females and Males of Reproductive Potential subsections of labeling for human prescription drug and biological products. This guidance provides information and recommendations for preparing subsections 8.1 Pregnancy, 8.2 Lactation, and 8.3 Females and Males of Reproductive Potential of the USE IN SPECIFIC POPULATIONS section.

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