Zdrowie i gospodarka · 8.02.2005
Draft Guidance for Industry on Clinical Lactation Studies-Study Design, Data Analysis, and Recommendations for Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling."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.