Publication and effects of FDA's new rule for pregnant and lactational women / 中国药学杂志

ABSTRACT

OBJECTIVE: To investigating the Pregnancy, Lactation, and Reproductive Potential Labeling for Human Prescription Drug and Biological Products-Content and Format, and we provide lessons for China's future revolution for the use of drug for pregnant women. METHODS: We analyzed and summarized the materials about the new system, and discussed history, letter risk categorization system, the preparation, new system, the effects of new rule. RESULTS: The new rule eliminates letter risk categorization system (ABCDX). The new system not only combines different parts of the previous rule but also adds a new part-"Females and Males of Reproductive Potential". CONCLUSION: Clinical pharmacists will work better with the new rule, thus should take lessons of FDA's revolutions for rules on pregnancy, and take steps to improve the safety measures for pregnant women.