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Home » OGD Aims To Minimize RTR ANDAs With Risk-Based Approach to DMFs
OGD Aims To Minimize RTR ANDAs With Risk-Based Approach to DMFs
July 12, 2013
With 1,250 drug master files submitted for completeness assessment (CA) review since GDUFA’s Oct. 1, 2012 implementation date, the FDA’s Office of Generic Drugs (OGD) has hired additional staff and prioritized the review of DMFs using a risk-based tiered approach.