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New SAE Reporting Regulation November 5, 2010

Posted by Michael Hamrell in Regulatory Thoughts.

On September 29, 2010, the FDA announced the long awaited Final Rule on changes and updates to the adverse event reporting regulations. This Final Rule is based on part on the proposed rule published back in 2003. In that proposal, FDA had proposed to amend, change and modify some of the requirements and details regarding adverse event reporting for investigational products and approved products in the marketplace. The Final Rule only deals with investigational products and safety reporting. The FDA indicated that accompanying rule will be published later to cover post-approval safety reporting. The Rule will go into effect in 180 days, on March 28, 2011.

This final rule codifies the agency’s expectations for the review, evaluation, and submission of safety information. It also implements internationally harmonized definitions and reporting standards based on the ICH Guidances (ICH E2A). The FDA hopes that the changes will improve the usefulness of IND safety reports and in particular, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug. One important change is the inclusion now of ‘suspected’ serious adverse events as part of the definition of what requires expedited reporting. There are also new requirements regarding review and evaluation of safety information, monitoring of the safety database and only reporting to FDA events for which there is evidence to suggest a causal relationship between the drug and event. The new rule also will require sponsor to report any clinical important increase in the rate of a serious event over that already listed as an expedited report.

Obviously, the goal of these changes is to improve the FDA oversight of critical safety information and provide better protection for subjects enrolled in clinical trials. In addition, for the first time FDA now will require that companies conducting Bioequivalence studies also must report serious adverse events to the FDA according to the same time frames. In the past these studies that are largely conducted without an IND, were not subject to safety reporting requirements. A Sponsor or CRO will now be required to report all serious adverse events, from either treatment group, as a 15 day expedited report.

For anyone involved in or overseeing the conduct of clinical trials, this will require some changes to the way we collect, process, evaluate and report safety information during clinical trials.

For more details, view the Draft Guidance on the new reporting requirements at: Draft Guidance on Safety Reporting



1. GarciaDelz - November 18, 2010

I have the same opinion with most of your points, but some need to be discussed further, I will hold a small talk with my partners and maybe I will ask you some suggestion soon.

– Henry

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