FDA Rolls Out Expectations for Biosimilars, Soon-to-Be Biologics

Discussion in 'Pharma/Biotech Companies - In the News' started by cafead, Dec 12, 2018 at 12:32 AM.

  1. #1 cafead, Dec 12, 2018 at 12:32 AM
    cafead

    cafead Administrator
    Staff Member

    Joined:
    Nov 21, 2001
    Messages:
    33,046
    Likes Received:
    3
    via The US Food and Drug Administration (FDA) on Tuesday released two new draft Q&A guidance documents on biosimilar development and the deemed to be a license provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as well as two final guidance documents on the same topics and one proposed rule amending the definition of a biological product.

    article source
     
    Quote

Reply to Thread