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Current Considerations on Real-World Evidence Use in FDA Regulatory Submissions

Examples and decision making from the Center for Devices and Radiological Health's Peripheral Interventional Devices Branch.

By Eleni Whatley and Misti Malone

The Value of Propensity-Matched Registry Data for New Device Evaluation

Novel use of real-world evidence with core lab imaging to create a control group for new medical device evaluation.

By Jack L. Cronenwett, MD; Eleni Whatley, PhD; Misti Malone, PhD; Cassandra Svendsen, BSME, MSBE; Michael J. Kallok, PhD; Kenneth Ouriel, MD; and Jens Eldrup-Jorgensen, MD

United States Regulatory Perspectives on Paclitaxel in PAD

Moderator Dr. Gary Ansel asks representatives from the FDA’s Center for Devices and Radiological Health about controlling for ascertainment and investigator bias in future vascular device trials, potential changes for drug-based device approvals, how the agency weighs the level of data required for approval of new vascular devices, the statistical strength of the data from general use studies, and the level of data needed to update FDA’s position on paclitaxel-containing devices.

With Eleni Whatley, PhD; Misti Malone, PhD; Sara Royce, PhD; and Kenneth Cavanaugh, PhD

Interventional Oncology: Precision in Practice

By Ripal Gandhi, MD, FSVM, and David M. Liu, MD, FRCPC, FSIR

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

RAPID Pathways’ Approach to an Urgent Safety Signal

Discussing the challenges, opportunities, and lessons learned from paclitaxel in PAD.

By Daniel J. Bertges, MD; Mitchell W. Krucoff, MD; Aaron Lottes, PhD, MBA; Misti Malone, PhD; George Papandreou, PhD; Sara Royce, PhD; and Eleni Whatley, PhD