NOVEMBER 18, 2016

An Overview of GDUFA

Introduction to The Office of Generic Drugs (OGD) The Office of Generic Drugs (OGD) reports directly to the Director of the Center for Drug Evaluation and Research (CDER). The OGD’s mission is to ensure safe, effective, and affordable medicines for the American public. The OGD helps ensure that human generic drug products are thoroughly tested and…

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