Tag Archives: guidances

July, 2016

April, 2015

  • 29 April

    FDA Issues Three Final Guidance Documents on Biosimilars

    The US Food and Drug Administration (FDA) has issued three long-awaited documents with final guidance on biosimilars. In 2010, the agency passed the Biologics Price Competition and Innovation Act (BPCI) under the Patient Protection and Affordable Care Act. In 2012, the FDA released the first guidance documents in draft form. …