Pregnancy Labeling Changes May Spur Research, FDA Says
This article was originally published in The Pink Sheet Daily
Final regulation eliminates use of letter-based categories to designate level of risk during pregnancy and lactation; in a change from the 2008 proposed rule, information relevant to drug effects on reproductive potential will now be housed in dedicated section.
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Risk Communication Advisory Committee will opine on impact that Pregnancy and Lactation Labeling Rule has had in conveying safety evidence useful to making prescribing decisions for pregnant patients and whether current labeling language can be improved upon.
FDA’s final rule includes narrative summaries of risk information about use during pregnancy and lactation, and it creates a new section relevant to drug effects on reproductive potential.
Proposed rule creates prominent role for registries and a new labeling format that would group risk information into three sections.