Zenosis are pleased to announce the release of a new module The ANDA: Requirements for obtaining approval for a generic product in the USA.

This module will provide an understanding of FDA expectations and will provide the necessary background knowledge to effectively plan, gather and assemble the appropriate documentation for making an ANDA submission.

A practical knowledge regarding the development of checklists and timelines to assure the success of an application and a contrast of the ANDA process to an NDA submission will also be provided.