Tag: FDA

New Research: FDA Pilot Compendium Intended to Foster Patient-Focused Drug Development Needs “Fine-Tuning”

Lawrenceville, NJ, USA—August 22, 2018—Value in Health, the official journal of ISPOR (the professional society for health economics and outcomes research), announced today the publication of a scoping review of the US Food and Drug Administration (FDA) Pilot Clinical Outcome

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What Is Patient Experience Data? The Regulatory Perspective

Defining Patient Experience Data in Light of the US 21st Century Cures Act Baltimore, MD, USA—May 21, 2018—ISPOR, the professional society for health economics and outcomes research, held a session, “What Is Patient Experience Data? The Regulatory Perspective [W2],” this

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ISPOR “ON THE ROAD” IN 1ST QUARTER 2016

ANNOUNCEMENT  ISPOR “ON THE ROAD” IN 1ST QUARTER 2016  Princeton, NJ—April 5, 2016—The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) attended a number of industry meetings during the first quarter of 2016. The following is a sampling of ISPOR’s

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FDA Actions Against Misleading Health Economic Promotions, 2002-2011

Boston, MA, USA – The study, “FDA Actions Against Health Economic Promotions, 2002-2011,” published in Value in Health, the official journal of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR), investigated FDA regulatory actions against drug companies’ health economic promotions from

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