Pregnancy and lactation drug labeling

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  • The 2015 FDA Pregnancy and Lactation Labeling Rule (PLLR) replaces the previously used pregnancy categories (A, B, C, D, X) and creates new labeling categories
    • Drugs approved by the FDA after the PLLR final rule will no longer be assigned a pregnancy category letter
  • New drug labeling categories:
    • 8.1 - Pregnancy (including labor and delivery)
    • 8.2 - Lactation (including nursing mothers)
    • 8.3 - Females and Males of reproductive potential
  • Labels will provide a narrative summary of risk and will summarize available human and animal risk data.

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