'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.
You may also be interested in...
US FDA: Sure, You Can File An Appeal – But We’d Rather You Not
In a couple of companion guidances, the US FDA has outlined how sponsors and other stakeholders can file a request to appeal a regulatory decision they disagree with. While processes are in place to challenge agency decisions, regulators say they prefer parties resolve them with agency staff before resorting to filing a formal appeal.
Speaking Of Medtech, Ep. 10: FDA’s TAP Pilot
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?
Thumbs Up: FDA Authorizes Weight Loss Suturing Systems From Apollo Endosurgery
People with obesity now have new tools to help them lose weight, thanks to the US agency’s de novo authorization.