Fed Regist. 2014 Dec 4;79(233):72063-103.
The Food and Drug Administration (FDA) is amending its regulations governing the content and format of the "Pregnancy," "Labor and delivery," and "Nursing mothers" subsections of the "Use in Specific Populations" section of the labeling for human prescription drug and biological products. The final rule requires the removal of the pregnancy categories A, B, C, D, and X from all human prescription drug and biological product labeling. For human prescription drug and biological products subject to the Agency's 2006 Physician Labeling Rule, the final rule requires that the labeling include a summary of the risks of using a drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation. The final rule eliminates the "Labor and delivery" subsection because information about labor and delivery is included in the "Pregnancy" subsection. The final rule requires that the labeling include relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males of reproductive potential. The final rule creates a consistent format for providing information about the risks and benefits of prescription drug and/or biological product use during pregnancy and lactation and by females and males of reproductive potential. These revisions will facilitate prescriber counseling for these populations.
美国食品药品监督管理局（FDA）正在修订其关于人用处方药和生物制品标签“特定人群用药”部分中“妊娠”“分娩”和“哺乳期妇女”子部分的内容和格式的规定。最终规则要求从所有人用处方药和生物制品标签中删除妊娠类别A、B、C、D和X。对于适用该机构2006年《医师标签规则》的人用处方药和生物制品，最终规则要求标签包括在妊娠和哺乳期使用药物的风险总结、支持该总结的数据讨论，以及有助于医疗保健提供者做出处方决定并就妊娠和哺乳期用药向女性提供咨询的相关信息。最终规则取消了“分娩”子部分，因为有关分娩的信息已包含在“妊娠”子部分中。最终规则要求标签为有生殖潜力的女性和男性开处方的医疗保健提供者提供有关妊娠检测、避孕和不孕的相关信息。最终规则创建了一种一致的格式，用于提供关于在妊娠和哺乳期以及有生殖潜力的女性和男性使用处方药和/或生物制品的风险和益处的信息。这些修订将便于为这些人群的处方者提供咨询。
