Article | September 2020
Regulatory Update: Paclitaxel in 2020 and Beyond
An interview with representatives from the FDA’s Center for Devices and Radiological Health on the current state of paclitaxel-coated device use, including safety, new data, and effects on the peripheral trial landscape.
With Eleni Whatley, PhD; Sara Royce, PhD; and Misti Malone, PhD
Article | September 2019
Paclitaxel Post-Panel: FDA Discusses What's Next From a Regulatory Perspective
An interview with representatives from the FDA Center for Devices and Radiological Health on the key updates to the letter to health care providers, lessons learned for future trials and follow-up protocols, and additional plans for monitoring in the future.
With Eleni Whatley, PhD, and Andrew Farb, MD
Article | August 2016
Registry Assessment of Peripheral Interventional Devices (RAPID)
Developing a minimum core dataset for total product life cycle device evaluation across multiple data sources: a step toward establishing a National Evaluation System for Health Technology for peripheral intervention devices.
By Jose Pablo Morales, MD; Jack Cronenwett, MD; and Robert Thatcher, MBA; on behalf of the RAPID Project Collaborators