Pregnancy and lactation drug labeling: Difference between revisions
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==Background== | ==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== | ==See Also== | ||
*[[Drug pregnancy categories]] | |||
==External Links== | ==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== | ==References== | ||
<references/> | <references/> | ||
[[Category:OBGYN]] | |||
[[Category:Pharmacology]] | |||
Latest revision as of 20:07, 31 December 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)