Standards & Regulation

May 04, 2016
PTSM: Pharmaceutical Technology Sourcing and Management
Progress is being made, but work remains to be done. Brian Daleiden, vice president of marketing at TraceLink, discusses the state of the industry, as companies attempt to meet complex, and changing, global requirements.
May 03, 2016
A federal judge entered an order of permanent injunction against Paul W. Franck, the owner and operator of several compounding pharmacies in Florida.
May 02, 2016
Pharmaceutical Technology
Revisions and updates for the 9th Edition of the European Pharmacopoeia result in changes to more than half of the content.
May 02, 2016
Pharmaceutical Technology
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.
Apr 29, 2016
Immuno-oncology drugs are demonstrating patient benefits, but growing resistance to the high cost has implications for patients, market access, and manufacturers.
Apr 29, 2016
By Pharmaceutical Technology Editors
The agency recommends the approval of Zavicefta to treat infections caused by resistant bacteria.
Apr 29, 2016
By Pharmaceutical Technology Editors
The agency extends the indication of the drug in combination with bendamustine.
Apr 29, 2016
By Pharmaceutical Technology Editors
The agency found no differences in risk of pneumonia for different products.
Apr 28, 2016
By Pharmaceutical Technology Editors
The agency holds a workshop to strengthen collaboration with healthcare providers.
Apr 27, 2016
By Pharmaceutical Technology Editors
The company voluntarily recalls product due to particulate matter.
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