Painting a Better Picture of Quality
Journal
The Medicine Maker
Type
newspaper article
Date Issued
2015-10-12
Author(s)
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 And more recently, the FDA published its draft guidance for industry related to the quality metrics request (1).
Language
English
HSG Classification
contribution to practical use / society
HSG Profile Area
SoM - Business Innovation
Refereed
Yes
Publisher
Texere Publishing (Knutsford)
Volume
12
Number
0915
Start page
17
End page
18
Pages
2
Subject(s)
Division(s)
Eprints ID
245484