Zdrowie i gospodarka · 11/07/2014

FDA Releases Draft Guidance on Abbreviated New Drug Application Submissions Under GDUFA

The FDA is releasing a draft guidance document to help industry prepare for amendments to abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) under the Generic Drug User Fee Amendments of 2012 (GDUFA), which aims to clarify the application of performance metric goals for these submissions.