[Ajay Shah]

Reply To: IND "in-effect" US Importation – Benchmark

The “FDA Acknowledge Letter” is provided by FDA to our Regulatory Representative within 5-10 business days after new IND submission. We do not include this letter with import but it’s available to provide to Customs/FDA if shipment is held up due to IND “not active/opened”.

Once IND is active/open, we reference the IND # on import documentation so Customs/FDA can reference the specific IND for product being imported.