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SMALL ENTITY COMPLIANCE GUIDE

Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format Guidance for Industry December 2014

Draft

Not for implementation. Contains non-binding recommendations.

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance is intended to help small businesses better understand and comply with the new content and format requirements of the Pregnancy, Lactation, and Females and Males of Reproductive Potential subsections of labeling for human prescription drug and biological products.2 On December 4, 2014, we published the final rule “Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling,” referred to as the “Pregnancy and Lactation Labeling Rule” (PLLR, or final rule, 79 FR 72064).3 The final rule requires that the former “Pregnancy,” “Labor and delivery,” and “Nursing mothers” subsections of the USE IN SPECIFIC POPULATIONS section of the labeling for human prescription drug and biological products be replaced by the three subsections entitled Pregnancy, Lactation, and Females and Males of Reproductive Potential.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.