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GUIDANCE DOCUMENT

Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling February 2005

Draft

Not for implementation. Contains non-binding recommendations.

Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling

Docket Number:
2005D-0030
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Clinical Lactation Studies—Study Design, Data Analysis, and Recommendations for Labeling.” This guidance discusses agency recommendations on how and when to conduct clinical lactation studies and how to assess the influence of drugs or biologic products on lactation. The goals of this guidance are to provide the basic framework for designing, conducting, and analyzing clinical lactation studies and to stimulate further study and research to assist in rational therapeutics for lactating patients.


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Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2005D-0030.