Analysis Looks at ICER’s FDA Outreach Plan

February 21, 2020

A recent analysis by the Pink Sheet spotlights a new initiative by the Institute for Clinical and Economic Review (ICER) which aims to bolster its patient-engagement efforts.

One component of its new Patient Engagement Program includes performing outreach to the Food and Drug Administration (FDA) on the importance of considering input from patients and patient organizations.

“At the conclusion of each review, ICER will invite participating patient groups for a formal debrief on the experience,” ICER said in a statement on its updated value assessment framework. “In addition, ICER will offer to co-author and promote a letter to the FDA and other stakeholders with proposals for improving the generation of specific patient-relevant data as part of the drug development process in that disease area.”

To read the Pink Sheet’s analysis, click here. (Paid subscription required)

Click here to read the press release.

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