Complex ANDAs To Be Allowed Pre-Submission Product Meetings
FDA will be able to give scientific advice and sponsors can familiarize reviewers with upcoming generic applications for complex products under new provision in GDUFA II.
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GDUFA II's fee structure shifts burden from manufacturers to sponsors though 'ANDA holder fee.'
GDUFA II gives certain generics the possibility of an even faster review clock, which burnishes FDA's credentials in the drug pricing debate, but in order to take advantage, applications will need to be of high quality in addition to addressing a public health priority.
With EpiPen injector patent-protected and patients accustomed to its use, finding a substitutable generic device may prove difficult.