Tag Archives: Guidance documents

May, 2015

  • 13 May

    FDA Unveils New Guidance Document for Biosimilars

    On Tuesday, the US Food and Drug Administration (FDA) released a revised document providing additional insight into how the agency plans to regulate biosimilars. The newly-released guidance document that answers common questions from companies interested in developing biosimilars, biologics license application (BLA) holders and other interested parties. The document, Biosimilars: …