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Home » OGD Aims to Minimize “Refuse-to-Receive” ANDAs With Risk-Based Approach to DMF Review
OGD Aims to Minimize “Refuse-to-Receive” ANDAs With Risk-Based Approach to DMF Review
July 5, 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 has hired additional staff and prioritized the review of DMFs using a risk-based tiered approach.