FDA Ends ANDA 'Reviews' To Streamline Approval Process
Instead, US agency will conduct 'assessments' of generic drug applications, according to new MaPP.
You may also be interested in...
Like ANDA evaluations, US FDA plans to use the word assessment to describe them for NDAs and BLAs.
Gottlieb Leaves FDA Feeling Good About Generic Approvals, But Concerned About Innovative Competition
In interview with the Pink Sheet, US FDA Commissioner Scott Gottlieb offers a final reflection of his time as commissioner.
US FDA commissioner outlines plans to allow partial submissions as soon as database locks and to create joint sponsor-agency review documents.