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Ah Ha!  Guidance from FDA on Elemental Impurities Issues

It looks like our guess was correct, and it also looks like OGD either liked our suggestion or, on its own initiative, decided to provide guidance to ANDA applicants concerning the best way to handle the submission of documentation on meeting the elemental impurities issue!

The one pager (here) discusses the fact that submission of the information as an unsolicited amendment as soon as possible, even if there is an extension of the GDUFA review clock of 3 months, would (in most cases) be the most expeditious way to respond to the issue and cause the least delay in approval if this were the only deficiency.  Kudos to OGD for getting this out to provide advice to industry.