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October 16, 2014
After almost two years of anticipation, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), has administration approval for organizational changes to bolster programs and policies to ensure drug quality.
October 10, 2014
The European Medicines Agency releases highlights from its Pharmacovigilance Risk Assessment Committee safety review meeting in October.
October 07, 2014
We?ve just opened new pharmaceutical laboratories! Our experienced scientists offer independent chemical and microbiological quality control testing of APIs, raw materials, finished products and medical devices in compliance with cGMP
September 25, 2014
FDA report details risk mitigation projects.
September 05, 2014
PDA surveys are designed to evaluate quality metrics practices at member organizations.
August 08, 2014
Cubist Pharmaceuticals voluntarily recalls certain lots of CUBICIN 500 mg in 10 mL single-use vials because of the presence of particulate matter.
August 04, 2014
Biopharma manufacturers must reduce the risk in their complex supply chains
August 01, 2014
Control charts that are properly constructed and maintained prevent false out-of-control signals and provide a useful method for monitoring a process.
July 02, 2014
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to ensure data integrity.
June 02, 2014
Statistical analysis shows how much testing is needed to deliver a reliable estimate result.