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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Foreign data: Sponsors interested in using data collected outside the U.S. to reduce the requirements for their PMA study or expand their labeling should meet with FDA early on, according to Office of Device Evaluation Interventional Cardiology Device Review Branch Chief Ashley Boam. "In the past, I think we've done a lot of 'well, we have this outside data, now what do we do with it?' We're trying to take the approach now of 'are you planning outside data? Let's talk ahead of time so that we'll know what we can do with it when you finish that study,'" she said Oct. 19 at the Transcatheter Cardiovascular Therapeutics meeting in Washington, D.C...
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