Does an IND application necessitate reanalysis of a Food Safety Plan?
Started by matthewcc, Jun 11 2018 10:08 PM
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
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Apologies for ignorance but what is "IND" ?
@Charles.C Sorry - it's an investigational new drug.
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