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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
January 01, 2019
Intellectual challenge, work/life balance, compensation, and an unclear business outlook create uncertainty among European bio/pharma employees.
December 29, 2018
Core functions and those funded by FY 2018 user fees are continuing, and 59% of the Agency’s staffers are being retained.
December 19, 2018
Despite ongoing efforts to address drug shortages, FDA now sees a rise in active shortages and in the duration of supply problems.
December 18, 2018
Agilent and other partners are funding development of Tapestri, a single-cell sequencing platform designed to help predict cancer relapse in individual patients and show the efficacy of gene-editing experiments.
The agency sent a warning letter to Cao Medical Equipment Co., Ltd. after inspectors found CGMP violations at the company’s Langfang, Hebei facility.
Asclemed USA Inc., dba Enovachem Pharmaceuticals is recalling the product due to labeling that incorrectly states that stoppers do not contain latex.
December 13, 2018
FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.
December 12, 2018
New FDA guidance developed to identify lapses in data integrity and promote best practices.
FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.
December 10, 2018
FDA has approved Truxima (rituximab-abbs), a biosimilar to Roche’s anti-cancer biologic, Rituxan (rituximab).