Zdrowie i gospodarka · 09/05/2019

Clinical Lactation Studies: Considerations for Study Design; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Clinical Lactation Studies: Considerations for Study Design." This guidance reflects FDA's current recommendations to sponsors regarding lactation studies during drug development. This guidance provides recommendations to facilitate the conduct of lactation studies. Such studies can inform breastfeeding with drug use recommendations included in the Lactation subsection of labeling. The recommendations in this guidance also reflect discussions from the 2007 Pediatric Advisory Committee meeting and the 2016 Lactation Workshop, which considered how data from clinical lactation studies can inform the safety of a drug when used during lactation. This guidance replaces the draft guidance for industry entitled "Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling" issued February 2005.