FDA Holds First Patient Engagement Advisory Committee Meeting
By Michael Mezher -
Published 12 October 2017
The US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time on Wednesday and Thursday to give the agency input from patients on clinical trials for medical devices.
Categories: News, US, FDA, Clinical, Medical Devices
Tags: Patient Engagement, PEAC, Patient Engagement Advisory Committee, Patient Reported Outcomes, Patient Preference Information
FDA to Systematically Incorporate Patient Preferences into Device Approvals
By Alexander Gaffney, RAC -
Published 13 May 2015
US medical device regulators at the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) have unveiled a proposed framework for the collection and use of patient preference information (PPI) in medical device development.
Categories: News, US, CDRH, Medical Devices, Regulatory strategy
Tags: PPI, Patient Preference Information, Guidance, Draft Guidance