Regulatory Open Forum

Hi all,

For drug/biologic INDs supported by a Phase 1-enabling toxicology study(s), we have often taken the option to submit a draft unaudited study report(s) due to tight study start timelines. Has anyone had experience with this strategy now that we are in the era of SEND datasets being required for tox studies? Specifically, can an unaudited draft toxicology study report be submitted without a SEND dataset, or must an unaudited/draft SEND dataset also be submitted with the unaudited draft study report?

Thanks for sharing your recent experiences with FDA on this topic.

Best,

Marshall

Hi all,

For drug/biologic INDs supported by a Phase 1-enabling toxicology study(s), we have often taken the option to submit a draft unaudited study report(s) due to tight study start timelines. Has anyone had experience with this strategy now that we are in the era of SEND datasets being required for tox studies? Specifically, can an unaudited draft toxicology study report be submitted without a SEND dataset, or must an unaudited/draft SEND dataset also be submitted with the unaudited draft study report?

Thanks for sharing your recent experiences with FDA on this topic.

Best,

Marshall

Hi Marshall,

I agree with the last response. We are in the same situation and so we asked the FDA about this via email. They met to discuss and this was their response:

"Per the Scope of SEND in Section 4.1.3.4.1 of the Study Data Technical Conformance Guide (https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources), SEND is required for study types modelled in an FDA-supported SEND Implementation Guide (SENDIG), as listed in the FDA Data Standards Catalog, when the submitted study report is needed to assess and support the safety of the proposed clinical investigations. The study report status or the finalization of the study report (i.e., draft, interim or final) does not impact whether the SEND requirement applies. We refer you to Section 4.1.3.4.1 of the Study Data Technical Conformance Guide for further information on the scope of SEND for studies modeled in the SENDIG version 3.0, version 3.1, and version 3.1.1 (single-dose toxicity, repeat-dose toxicity, carcinogenicity, cardiovascular and respiratory safety pharmacology)."

Original Message:
Sent: 21-Sep-2023 11:00
From: Marshall Hoke
Subject: SEND Datasets for Unaudited Draft Toxicology Reports

Hi all,

For drug/biologic INDs supported by a Phase 1-enabling toxicology study(s), we have often taken the option to submit a draft unaudited study report(s) due to tight study start timelines. Has anyone had experience with this strategy now that we are in the era of SEND datasets being required for tox studies? Specifically, can an unaudited draft toxicology study report be submitted without a SEND dataset, or must an unaudited/draft SEND dataset also be submitted with the unaudited draft study report?

Thanks for sharing your recent experiences with FDA on this topic.

Best,

Marshall