Ver el código de «Pregnancy and lactation drug labeling»

==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==
*[[Drug pregnancy categories]]

==External Links==
*[http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm FDA Pregnancy and Lactation Rule]
*[https://www.gpo.gov/fdsys/pkg/FR-2014-12-04/pdf/2014-28241.pdf FDA PLLR Final Rule PDF]
*[http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_pi.pdf Zepatier Drug Label (Conforms to PLLR standards)]

==References==
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[[Category:OB/GYN]]