• 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

    Off-Label Use Case on Potential Path to Supreme Court, With Wide-Ranging Implications for FDA

    A debate in Arizona which in part focuses on the authority of the US Food and Drug Administration (FDA) to regulate the use of drug products may soon find its way before the Supreme Court, with major implications for a wide range of products. Background The matter in question concerns a federal court case, Planned Parenthood v. Humble , challenging a 2012 Arizona law which makes it illegal to use the drug RU-486 (mifepristone) for uses not explicitly approved by FDA....