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ABSTRACT

The drug development process in the United States includes extensive pre-clinical testing and a series of clinical trials designed to explore the safety and efficacy of a new drug entity. As part of this process, animal studies are conducted to assess the effects of the new drug on the reproductive process. These studies, called developmental and reproductive toxicology studies, form the basis for the information included in the current pregnancy subsection of the drug label. The new drug's effects on the human fetus are gathered through post-marketing studies, usually observational registries. There is usually no information regarding the dose appropriate for pregnancy. The usual adult dose is assumed to be appropriate. Proposed changes to the current pregnancy subsection would replace the categories with narrative text, allow more detailed clinical management advice, including inadvertent fetal exposure, and provide a summary of risks associated with the drug. The sections on fertility, pregnancy and lactation would be combined, since they are a continuum. A provision is also being made to incorporate information from pharmacokinetic and pharmacodynamic studies relevant to pregnancy.