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The final rule removed the pregnancy letter categories, and created descriptive subsections for pregnancy exposure and risk, lactation, and effects to reproductive potential for females and males. Labeling changes from this rule began on June 30, 2015, with all submissions for prescription drugs and biological agents using the labeling changes ...
[96] [97] [98] In 2014, however, the FDA has developed a "Pregnancy and Lactation Labeling Rule (PLLR)" which requires product labels to include specific information related to the safety and effectiveness of medications to pregnant and lactating women. This ruling has removed the requirement of stating pregnancy categories in prescription drug ...
The FDA pregnancy classification is removed from this infobox, and does not show any more. By FDA, it is replaced by the Pregnancy and Lactation Labeling Rule (PLLR) of December 2014. The PLLR is descriptive, and not suitable for this infobox. [1]
This page was last edited on 11 April 2015, at 20:06 (UTC).; Text is available under the Creative Commons Attribution-ShareAlike License 4.0; additional terms may ...
Use in specific populations (pregnancy, lactation (breast-feeding), females and males of reproductive potential, pediatric, geriatric) Drug Abuse and Dependence - provides information regarding whether prolonged use of the medication can cause physical dependence (only included if applicable)
Pregnancy category was required on the drug label for systemically absorbed medications with the risk of fetal injury, which is now replaced with pregnancy and lactation labeling rule (PLLR). [26] In addition to pregnancy category requirements on information of pregnancy, labor and delivery, and nursing mothers, PLLR also includes information ...
The FDA pregnancy classification is removed from this infobox, and does not show any more. By FDA, it is replaced by the Pregnancy and Lactation Labeling Rule (PLLR) of December 2014. The PLLR is descriptive, and not suitable for this infobox. [1]
Under the FDA's updated Pregnancy and Lactation Labeling Rule which eliminated the lettered pregnancy categories and came into effect in 2015, tazarotene was determined to be contraindicated in pregnancy. [12]