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October 02, 2016
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
A number of organizations have analyzed and estimated the size of pharma’s counterfeit and diversion problem.
As criminals duplicate the latest overt security technologies, pharmaceutical manufacturers are evaluating covert and layered approaches to fight counterfeiting, theft, and illegal product diversion.
September 23, 2016
Hebei Yuxing Bio-Engineering Co. Ltd. was cited for data integrity violations.
September 14, 2016
The agency provides a qualified context of use for the biomarker plasma fibrinogen.
September 02, 2016
Siegfried Schmitt, principal consultant, PAREXEL International, discusses how to find the root cause of the problem.
Industry experts discuss recent trends in modular manufacturing.
The media blitz surrounding drug shortages has stopped, but critical medications that have no substitutes remain in short supply. Can new approaches turn this situation around?
September 01, 2016
FDA found no observations during recent inspection of Regis Technologies manufacturing site.
Evonik’s parenteral drug delivery and commercial drug product manufacturing in Alabama passes EU GMP inspection.