• Regulatory NewsRegulatory News

    FDA Approves New Label for Lower Dose of Abortion Drug

    In a win for public health advocates, the US Food and Drug Administration (FDA) on Wednesday approved new labeling for the abortion drug Mifeprex (mifepristone), supporting its safety and effectiveness when taken at lower doses and later in pregnancy. FDA first approved mifepristone in 2000 as a 600mg dose to end a pregnancy within 49 days of a woman's last menstrual period when taken in combination with misoprostol. However, even before mifepristone was approved, stud...
  • Regulatory NewsRegulatory News

    FDA Attitude on Off-Label Prescribing Central to Arizona Abortion Drug Access Case

    A federal court has ruled that Arizona's attempts to limit access to an abortion drug known as RU-486 (mifepristone) are unconstitutional, drawing on the US Food and Drug Administration's (FDA) authority to support its ruling. Background The case involved Arizona's attempts to restrict the use of RU-486, which is approved by FDA for use in terminating pregnancy within 49 days of the start of a woman's last menstrual period. As FDA explains on its website , the ...