• RF Quarterly

    A history of expedited pathways: Breakthrough therapy designation, PRIME, Sakigake, and ILAP

    It can take at least a year to 18 months to get a new medicinal product approved in the US, European Union, or United Kingdom. Over the last decade, regulators have introduced initiatives to shorten the time to market for medicines that address seriously debilitating and life-threatening conditions. This article reviews the initiation and achievements of US Food and Drug Administration’s (FDA’s) breakthrough therapy designation (BTD), the European Medicines Agency’s (EMA) ...
  • Regulatory NewsRegulatory News

    FDA explains when it will rescind breakthrough designations

    The US Food and Drug Administration (FDA) on Thursday released draft guidance explaining its thought process for rescinding breakthrough therapy designation (BTD) during its evaluation of a drug.   While FDA has long asserted its authority to rescind or withdraw BTDs, the new guidance will add clarity for sponsors as to when the agency might revoke the designation. Since designation was created under the Food and Drug Administration Safety and Innovation Act in 2012,...