Search Results for 'CBE'

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  • CBE 30

    March 25, 2013
    Similar to Changes Being Effected (CBE). A filing with the FDA to gain approval of a moderate change, i.e., a change that has a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as…

  • CBE

    March 25, 2013
    See Changes Being Effected.…

  • CBER

    February 27, 2012
    See Center for Biologics Evaluation and Research.…

  • Center for Biologics Evaluation and Research (CBER)

    February 27, 2012
    The FDA successor to the Bureau of Biologics concerned with biologic drugs and with the new protein and peptide drugs arising from biotechnology. According to its charter, CBER is responsible for ensuring: The safety of the U.S. entire blood suppl…

  • FDA Proposes Change To CBE Supplement Rule

    Gary C. Messplay, J.D. || April 30, 2008
    Proposed rule to codify long-standing policy stirs debate