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Since pregnant and lactating women have historically been excluded from drug development trials, safety studies need to be conducted postapproval. This study evaluated FDA's Post Marketing Requirements for pregnancy and lactation studies from 2007 to 2020, and identified trends and potential future opportunities. The number of studies required to be conducted in the postmarketing setting was compared with the number of new drugs approved during the same time period. We excluded drugs that were approved for use in men, children, or postmenopausal women. Since 2007, there has been an increase in pregnancy and lactation studies required to be conducted postapproval. However, only 16% of drugs that may be used in females of reproductive potential were issued a postmarketing requirement for a pregnancy and/or lactation study. The most common type of required pregnancy safety study was a …