Painting a Better Picture of Quality

Item Type Newspaper
Abstract

The FDA's approach to quality oversight has evolved in recent years, particularly with the establishment of the new Office of Pharmaceutical Quality (OPQ). OPQ exists within the Center for Drug Evaluations and Research (CDER) as a single unit dedicated to product quality with a simple mission: "to assure that quality medicines are available for the American public". In 2013, the FDA announced in the publication of the FDA Administration Safety and Innovation Act (FDASIA) that they intended to examine the use of selected quality metrics (the exact metrics will be decided upon and collected during an FDA quality metrics program) to support their risk-based inspection program. And more recently, the FDA published its draft guidance for industry related to the quality metrics request (1).

Authors Mänder, Christian & Friedli, Thomas
Projects Mänder, Christian (2014) Enhanced Quality Metrics - Overcoming the divide of Quality and Excellence [applied research project]
Journal or Publication Title The Medicine Maker
Language English
Subjects social sciences
HSG Classification contribution to practical use / society
HSG Profile Area SoM - Business Innovation
Refereed Yes
Date 12 October 2015
Publisher Texere Publishing (Knutsford)
Volume 12
Number 0915
Page Range 17-18
Number of Pages 2
Depositing User Dr. Christian Mänder
Date Deposited 19 Nov 2015 13:52
Last Modified 23 Aug 2016 11:22
URI: https://www.alexandria.unisg.ch/publications/245484

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Citation

Mänder, Christian & Friedli, Thomas: Painting a Better Picture of Quality. In: The Medicine Maker 12 (2015), 0915, S. 17-18.

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https://www.alexandria.unisg.ch/id/eprint/245484
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