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Revisión del 11:06 31 dic 2016
Background
- 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.
See Also
External Links
- FDA Pregnancy and Lactation Rule
- FDA PLLR Final Rule PDF
- Zepatier Drug Label (Conforms to PLLR standards)