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The only technical publication dedicated to readers who formulate, manufacture, or package solid dosage forms.

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  • December 20, 2019

SILVER SPRING, MD—The FDA’s Center for Drug Evaluation and Research (CDER) has reorganized the New Drugs Regulatory Program, requiring restructuring of the Office of New Drugs (OND) to create offices that align interrelated disease areas and divisions with more focused areas of expertise. The changes increased the number of OND offices that oversee review divisions from six to eight and the number of OND clinical divisions from 19 to 27 in addition to adding six non-clinical review divisions. The OND will also create cross-functional support offices of New Drug Policy, Drug Evaluation Sciences, Regulatory Operations, Operations, and Administrative Operations.