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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.
May 31, 2016
Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.
May 26, 2016
The agency cited Tai Heng Industry with CGMP deviations, including failure to ensure data integrity.
May 25, 2016
Sandoz is seeking approval for the same indications as Roche’s reference product MabThera.
May 24, 2016
FDA accepted for review Samsung Bioepis’ BLA for SB2, a biosimilar to Remicade (infliximab).
FDA cited BBT Biotech GMBH for failing to comply with current good manufacturing practice in its German API manufacturing facility.
May 19, 2016
The draft guidance helps companies design new treatments of chronic obstructive pulmonary disease.
May 18, 2016
The company recalls products due to sterility concerns.
May 17, 2016
The agency provides guidelines on generating histopathology data in nonclinical biomarker qualification studies.
May 16, 2016
FDA is advising there may be serious and potentially permanent side effects associated with taking fluoroquinolone antibacterial drugs consistently.