Category Archive: CDER

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

By | September 26, 2019 | BLA, CDER, FDA, NDA, Regulatory Affairs | Like |

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 six to eight—and increases the number of OND clinical divisions from our current 19 divisions to 27,

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ICH Q12 – Ready or Not, Here it Comes!

By | July 30, 2019 | Biologics, CBER, CDER, CMC, FDA, ICH | Like |

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 it focused on the draft International Conference on Harmonization (ICH) Q12 guideline (here) which addresses the technical and regulatory aspects of reporting post-approval changes to the regulatory bodies.