FDA publishes new draft guidances for industry

The US Food and Drug Administration (FDA) has published new  draft guidance for industry on making amendments to abbreviated new drug applications (ANDAs) under the Generic Drug User Fee Amendments (GDUFA II).

This guidance explains how the review goals established as part of GDUFA II apply to amendments to ANDAs or prior approval supplements (PASs), how submissions on amendments may affect an application’s review goal dates and how the FDA should review those that are submitted to ANDAs or PASs received prior to October 1, 2017, the GDUFA II review goals’ effective date.

Further  draft guidance has been submitted to assist ANDA applicants, answering questions regarding refuse to receive standards and the filing process in general.

The FDA is offering the public the chance to comment on both the draft guidance documents.