CDER SBIA Update: New Information from FDA

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New Information from FDA

1. FDA Draft Guidance: Safety Assessment for IND Safety Reporting

FDA has published a draft guidance for sponsors of investigational new drug application (IND) studies with recommendations for identifying and evaluating important safety information that must be submitted to FDA and all participating investigators under the IND safety reporting regulations (21 CFR 312.32).

Safety Assessment for IND Safety Reporting, was developed as a follow-on to the 2010 guidance for industry and investigators Safety Reporting Requirements for INDs and BA/BE Studies. During the evaluation of comments to the docket for the earlier guidance, FDA identified a need for additional guidance on IND safety reporting.

FDA believes this draft guidance will help sponsors develop a systematic approach for IND safety reporting for human drugs and biological products developed under an IND. The draft guidance provides recommendations on the composition and role of a safety assessment committee, aggregate analyses for comparison of adverse event rates across treatment groups, planned unblinding of safety data, reporting thresholds for IND safety reporting, and development of a safety surveillance plan.

It is critically important for sponsors to detect and report as early as possible serious and unexpected suspected adverse reactions and clinically important increased rates of previously recognized serious adverse reactions. Effective sponsor processes for a systematic approach to safety surveillance, coupled with IND safety reporting to FDA and all participating investigators (and subsequent reporting to involved institutional review boards), allows all parties to focus on important safety issues and to take actions to minimize the risks of clinical trial participation to human subjects.

FDA will host a webinar to discuss the draft guidance recommendations and will update stakeholders with details when available. Comments on this draft guidance will be accepted until February 16, 2016

2. Source Data Capture from Electronic Health Records

The FDA  is encouraging stakeholders to initiate eSource development projects, using established data and implementation standards for data in a regulated clinical research environment. This news is related to the recent Federal Register (FR) Notice released by the FDA in June 2015 encouraging organizations to propose demonstration projects and the September 2013 FDA Guidance encouraging use of electronic source data in the conduct of clinical investigations.