The quality assessment in the Office of Pharmaceutical Quality (OPQ) is matrixed across various sub-offices. This presentation will provide a high level overview of how a generic drug is evaluated in OPQ and provide specific details on the role of the Office of Lifecycle Drug Products which monitors drug quality aspects pre- and post-marketing and serves as the central hub for lifecycle management for generic drugs.

Quality assessment of generic drug products

251st National Meeting (2016)

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