If you have been procrastinating on setting up electronic submissions for your adverse event reports to the FDA, you might want to reconsider that decision. Earlier this year, the FDA published its final rule on MedWatch/eMDR reporting.

Although not much has changed in this final rule in regards to required content, the submission process, or submission timelines, the FDA has taken a large step closer to mandating 21st century technology. The final rule states that all required adverse events are to be submitted electronically by Aug. 14, 2015. The clock continues to tick….

Not sure if you’re handling this new reality properly? Well, here’s a quick way to find out. Are you (or your management) making statements like these?

“The FDA always delays; we will just wait and see.”

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