Search Results for PEAC

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Patient Engagement in Device Trials: FDA Meeting Discusses Challenges and Opportunities By Michael Mezher - Published 16 October 2017

Last week, the US Food and Drug Administration's (FDA) Patient Engagement Advisory Committee (PEAC) met for the first time to look at ways to increase patient engagement in clinical trials for medical devices.

Categories: News, US, FDA, Clinical, Medical Devices

Tags: Patient Engagement, PEAC

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 Considers Creating New 'Office of Patient Affairs' By Zachary Brennan - Published 13 March 2017

As part of efforts to better capture patients' perspectives, the US Food and Drug Administration (FDA) on Monday said it is considering establishing an "Office of Patient Affairs," to be tasked with supporting and coordinating patient engagement across the agency.

Categories: News, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: patient engagement and FDA, PEAC, patient perspectives, FDA patient advice

Califf: Patient Preferences Too Often Overlooked in Medical Product Development, Approvals By Zachary Brennan - Published 19 November 2015

As patients play a more active role in which regulated products are used in their care, the US Food and Drug Administration (FDA) is working on several programs to ensure patient perspectives have an effect on how those products are developed and approved, FDA commissioner nominee Robert Califf and other agency officials said in a JAMA Viewpoint published Thursday.

Categories: News, US, FDA, Advertising and Promotion, Communication, Drugs, Government affairs, Medical Devices, Preclinical, Regulatory intelligence, Submission and registration

Tags: patient engagement, FDA, patient preference, PEAC, medical device preferences

FDA’s CDRH Unveils First-Ever Patient Engagement Advisory Committee By Zachary Brennan - Published 18 September 2015

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Friday announced the establishment of the first-ever Patient Engagement Advisory Committee (PEAC) to ensure patient needs and experiences are included during the review of medical devices.

Categories: News, US, CDRH

Tags: CDRH, patient engagement, advisory committee, PEAC, Robert Califf