Regulatory Open Forum

Dear community,

My company submits an IND for a Phase 1. And FDA provides some non-hold comments.
Some of these comments require us to correct or add/update certain information in previously submitted pharmacology study reports.

My question is:
Do we need to provide report amendments ? Tabular summary of changes ? Or to prepare a new version of the reports ?
And does this apply when the corrections are minor ?

Thank you for your help.

Nathalie
New regulatory associate

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Nathalie DELESQUE TOUCHARD
Lauzerville
France
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This message was posted by a user wishing to remain anonymous

Report amendments plus a summary of changes made should suffice. Amendments should have version controls.
Original Message:
Sent: 26-Nov-2020 07:30
From: Nathalie DELESQUE TOUCHARD
Subject: Pharmacology study reports in IND submission

Dear community,

My company submits an IND for a Phase 1. And FDA provides some non-hold comments.
Some of these comments require us to correct or add/update certain information in previously submitted pharmacology study reports.

My question is:
Do we need to provide report amendments ? Tabular summary of changes ? Or to prepare a new version of the reports ?
And does this apply when the corrections are minor ?

Thank you for your help.

Nathalie
New regulatory associate

------------------------------
Nathalie DELESQUE TOUCHARD
Lauzerville
France
------------------------------