Zdrowie i gospodarka · 20/06/2017

FDA Releases Draft Guidance for Industry on Pre-Submission Facility Correspondence for Priority ANDA Submissions

The US Food and Drug Administration (FDA) has made available a draft guidance document outlining the requirements for pre-submission facility correspondence associated with priority abbreviated new drug application (ANDA) submissions, as part of the Generic Drug User Fee Amendments (GDUFA II) reauthorization for Fiscal Years 2018-2022.