The FDA's guidance for industry on 'Referencing Drug Products in ANDA submissions'

12 January 2021

Dr Nicola Davies

In October 2020, the US Food and Drug Administration issued guidance for industry entitled “Referencing Approved Drug Products in Abbreviated New Drug Application (ANDA) Submissions.”

This final guidance, based on a 2017 draft, provides clarification for current and potential ANDA applicants on the identification and correct use of key terms within their ANDA submissions.1 In this article, Dr Nicola Davies discusses the information that is included within this guidance and the importance of its publication for successful ANDA submissions.

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