CDER

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26
Sep
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CDER Office of New Drugs Reorganization and Impact on OPQ and Office of Translational Sciences Announced

By    Sep 26, 2019    BLA CDER FDA NDA Regulatory Affairs

CDER’s reorganization of the Office of New Drugs initiative was begun in 2017 and today the FDA announced it (here).  The goal was to increase the therapeutic areas more efficiently with a corresponding concentration of areas of expertise.  The FDA says, “the changes increase the number of OND offices that oversee our review divisions from […]

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30
Jul
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ICH Q12 – Ready or Not, Here it Comes!

By    Jul 30, 2019    Biologics CBER CDER CMC FDA ICH

California Separation Sciences Society (CaSSS) holds a two-day, highly interactive meeting with attendance from the biotechnology industry and global regulators each summer in the Washington, DC area (i.e., the CMC Strategy Forum).  This year the title of the forum was “The Future of Post-Approval Changes is Coming – Are You Ready for ICH Q12?” and […]

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