Quality Systems

Jul 02, 2017
Pharmaceutical Technology
The more pharma science and technology change, the more business and policy concerns stay the same.
Jul 02, 2017
Pharmaceutical Technology
Real-time alternatives to dissolution testing are required for continuous manufacturing to reach mainstream use.
Jul 02, 2017
Pharmaceutical Technology
CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.
Jun 29, 2017
By Pharmaceutical Technology Editors
The agency announced a plan to eliminate its existing orphan designation request backlog.
Jun 29, 2017
By Pharmaceutical Technology Editors
The agency determined additional guidance was needed to reduce regulatory compliance burden.
Jun 28, 2017
By Pharmaceutical Technology Editors
The directorate highlights its 2016 achievements.
Jun 27, 2017
By Pharmaceutical Technology Editors
The agency sent a warning letter to Raritan Pharmaceuticals, Inc. after an inspection found quality testing and misbranding violations.
Jun 27, 2017
By Pharmaceutical Technology Editors
The agency announced it is taking steps to increase competition within the prescription drug market.
Jun 26, 2017
By Pharmaceutical Technology Editors
Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.
Jun 23, 2017
By Pharmaceutical Technology Editors
The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.
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