FDA Issues PAS and DMF Guidances as GDUFA II Gets Underway
Following the launch of GDUFA II Oct. 1, the FDA released final guidances and timelines for reviewing generic prior approval supplements and API drug master files.
Source: Generic Line
Following the launch of GDUFA II Oct. 1, the FDA released final guidances and timelines for reviewing generic prior approval supplements and API drug master files.
Source: Generic Line