Completeness Assessment of Type II Active Pharmaceutical Ingredient Drug Master Files under Generic Drug User Fee Amendment: Review Metrics and Common Incomplete Items von Zhang, Huyi, Li, Haitao, Song, Wei, Shen, Diandian, Skanchy, David, Shen, Kun, Lionberger, Robert A., Rosencrance, Susan M., Yu, Lawrence X.

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Advancing pharmaceutical quality oversight during the lifecycle of generic drug products von Rosencrance, Susan M, Wu, Geoffrey K

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Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference von Yu, Lawrence X., Baker, Jeffrey, Berlam, Susan C., Boam, Ashley, Brandreth, E. J., Buhse, Lucinda, Cosgrove, Thomas, Doleski, David, Ensor, Lynne, Famulare, Joseph, Ganapathy, Mohan, Grampp, Gustavo, Hussong, David, Iser, Robert, Johnston, Gordon, Kesisoglou, Filippos, Khan, Mansoor, Kozlowski, Steven, Lacana, Emanuela, Lee, Sau L., Miller, Stephen, Miksinski, Sarah Pope, Moore, Christine M. V., Mullin, Theresa, Raju, G. K., Raw, Andre, Rosencrance, Susan, Rosolowsky, Mark, Stinavage, Paul, Thomas, Hayden, Wesdyk, Russell, Windisch, Joerg, Vaithiyalingam, Sivakumar

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