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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 […]

Of all the big decisions to be made when conducting a clinical trial, perhaps the biggest of them all is selecting the right CRO for the job. With all the moving parts inherent in a trial, it is critical to find the right partner, and one that can deliver results in a timely and cost-effective […]