BRIEF—FDA publishes draft guidance on ANDA submissions

The US Food and Drug Administration (FDA) has published draft guidance for generic drug developers.

This guidance is called ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs, and contains recommendations that can help applicants avoid delays in obtaining the final approval .

It is also hoped that the guidance will help to further the FDA’s aim of increasing the number of affordable medicines on the US market.