New FDA Draft Guidance on Safety Assessment for IND Safety Reporting

The new Draft Guidance on Safety Assessment for IND Safety Reporting is open for comments to be sent to FDA

This document provides guidance to sponsors on developing a systematic approach for investigational new drug application (IND) safety reporting for human drugs and biological products developed under an IND.

This guidance is a follow-on to the guidance for industry and investigators Safety Reporting Requirements for INDs and BA/BE Studies and provides recommendations for how sponsors of INDs can identify and evaluate important safety information that must be submitted to FDA and all participating investigators under the IND safety reporting regulations.

This guidance contains recommendations on the following: (1) the composition and role of a safety assessment committee, (2) aggregate analyses for comparison of adverse event rates across treatment groups, (3) planned unblinding of safety data, (4) reporting thresholds for IND safety reporting, and (5) the development of a safety surveillance plan.

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