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'Your Ombuddy': ORA's New Ombudsman Doesn't Want Device Firms To Be Terrified Of Her

Executive Summary

When you pick up the phone to contact US FDA, do you sweat? That's exactly the type of response that Jessica Zeller, the very first ombudsman for the agency's Office of Regulatory Affairs, wants to avoid. "I know you're terrified to call," Zeller says, but she wants industry to know that she considers herself to be an "ombuddy" to manufacturers.

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