Does an IND application necessitate reanalysis of a Food Safety Plan?

Hi everyone, does an IND application always necessitate reanalysis of a Food Safety Plan under FSMA?

'§117.170 Reanalysis' states that one reason that reanalysis would be required is "Whenever a significant change in the activities conducted at your facility creates a reasonable potential for a new hazard or creates a significant increase in a previously identified hazard..."  However, by its very nature an IND is novel and therefore a potential new hazard could be involved.

We are regulated under 21 CFR Part 117 and 21 CFR Part 111 in the United States.

Thank you,

Matthew

Apologies for ignorance but what is "IND" ?

@Charles.C Sorry - it's an investigational new drug.