Big or Small, FDA Wants to Hear About All Trial-Related AEs

May 25, 2012

Trial sponsors should notify the FDA about all adverse events brought to their attention by data monitoring committees (DMC), regardless of whether the safety issue is “serious” or not, according to an agency guidance.

The agency supports the additional reporting even though it runs counter to regulations. Currently, only DMC recommendations on serious adverse events (SAE) must be reported to the FDA, the April 20 guidance notes. The Office of Management and Budget is reviewing the guidance now under the Paperwork Reduction Act, and it should be published within the next few months if approved.

Sponsors should also tell DMCs about any FDA waivers of the expedited reporting requirements for SAEs, the guidance on the appropriate use and operation of DMCs adds.

When you’re dealing with the U.S. or EU — markets that each spend in excess of hundreds of billions per year on drugs, biologics and medical devices — you want to be certain that you’re well-armed in their differing adverse event reporting regulations.

Failure to understand the many differences between the U.S. and EU regulations can lead to delays in approval, repeat paperwork, additional costs or worse, outright denial of market access.

Overcome the challenge by attending FDAnews’ webinar this Wednesday, A World Apart Understanding Differences in EU and U.S. Drug and Device Adverse Event Reporting.

It’s a Virtual Conference, sponsored by FDAnews and featuring top experts who have been in the AER trenches. Without ever leaving the comfort of your office, you’ll gain practical knowledge that helps you assure you’re in full compliance. Register for the May 30 webinar today!