A Comparison of FDA and EMA Pregnancy and Lactation Labeling

Kappel, D; Sahin, L; Yao, L; Thor, S; Kweder, S

Kappel, D (通讯作者),US FDA, Off Global Policy & Strategy, Silver Spring, MD 20993 USA.

CLINICAL PHARMACOLOGY & THERAPEUTICS, 2023; 113 (6): 1251

Abstract

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have robust collaboration and dialogue around the need for data and ......

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