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  • Regulatory NewsRegulatory News

    Supreme Court Declines to Hear Case on Off-Label Prescribing Authority

    The US Supreme Court has refused to hear a challenge to an Arizona law that sought to limit the use of an abortion drug, avoiding a potential showdown over whether off-label prescribing is explicitly allowed under federal law, or simply tolerated. Background As Regulatory Focus has previously reported , the Supreme Court had been petitioned to hear an appeal of the federal court case  Planned Parenthood v. Humble —a case challenging a 2012 Arizona law which makes i...
  • Regulatory NewsRegulatory News

    FDA Planning Six New Drug, Device Regulations for 2015

    The US Food and Drug Administration (FDA) has released a list of regulations it plans to release in 2015, including six new rules set to affect pharmaceutical and medical device development. Background The list, known as FDA's "Unified Agenda," is published bi-annually as required by the Regulatory Flexibility Act of 1980 and Executive Order 12866. While the list is intended to serve as an overview of the agency's planned actions for a given year, in practice just a s...
  • 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....
  • FDA Publishes List of all Device Guidance Documents Planned for 2013

    The US Food and Drug Administration (FDA) has published a list of 23 medical device guidance documents it plans to publish during fiscal year 2013, part of the recently passed FDA Safety and Innovation Act (FDASIA) . Among FDASIA's numerous provisions is the Medical Device User Fee Act (MDUFA) , which established the fees and regulatory expectations for the medical device review process. As of right now, those processes largely exist in the abstract, awaiting further...
  • CDER Releases List of Upcoming Guidance Documents

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) released 5 March a list of all new and revised guidance documents that the agency plans to release during 2012. The list contains guidance documents related to: advertising biopharmaceuticals biosimilarity chemistry clinical/antimicrobial clinical pharmacology clinical/statistical combination products current good manufacturing practices/compliance drug safety informat...