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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.
October 13, 2016
Laboratoire Sintyl S.A. received an FDA warning letter for CGMP quality violations.
Wallace Cameron International was cited for not registering its Wishaw, Scotland facility with FDA.
October 12, 2016
FDA warned Nippon Fine Chemical Co. for refusing to allow FDA investigators to inspect sections of the company’s laboratory and equipment.
October 11, 2016
HHS entered into a contract with BioProtection Systems Corp. for commercial manufacturing tests of an Ebola vaccine.
Gamida Cell was granted FDA Breakthrough Therapy Designation for NiCord, a novel graft modality for bone marrow transplantation.
October 10, 2016
The authors describe some cases of container closure design flaws and actions taken by FDA to mitigate safety risks and increase patient acceptability.
The agency’s Patient-Focused Drug Development program completed its commitment ahead of schedule.
October 06, 2016
A report from the European Union Intellectual Property Office shows that the EU loses approximately €10.2 billion a year due to counterfeit medicines.
October 05, 2016
Value assessment initiatives are expected to have a major impact on drug use and reimbursement.
October 03, 2016
FDA’s Center for Drug Evaluation and Research provides an update on its safety initiatives.