| 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 And more recently, the FDA published its draft guidance for industry related to the quality metrics request (1).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 |
20 Jul 2022 17:26 |
| URI: |
https://www.alexandria.unisg.ch/publications/245484 |
Painting a Better Picture of Quality
