Priority Generic Drug Reviews: New FDA Draft Guidance
By Michael Mezher -
Published 19 June 2017
In preparation of its commitments under the second Generic Drug User Fee Amendments (GDUFA II), the US Food and Drug Administration (FDA) on Monday released a draft guidance laying out how sponsors can qualify for shorter review times for priority generic drugs.
Categories: News, US, FDA, Communication, Generic drugs, Submission and registration
Tags: Priority Generics, ANDA, Pre-Submission Facility Correspondence, PFC