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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.
August 27, 2018
The Senate approved a $159-million budget increase for FDA, to bring its resources up to $5.4 billion for 2019, including more than $2 billion in user fees.
August 24, 2018
FDA sent a warning letter to Kyowa Hakko Bio Co., Ltd. after inspectors found data integrity problems at the company’s Yamaguchi, Japan facility.
August 22, 2018
King Bio is recalling several of its kids and infant products due to possible microbial contamination.
August 17, 2018
FDA approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.
August 16, 2018
FDA sent a warning letter to Apotex Research Private Limited after investigators found current good manufacturing practice violations.
August 15, 2018
FDA published a resource guide to promote responsible opioid prescribing in the treatment of animals.
August 13, 2018
Westminster Pharmaceuticals, LLC is voluntarily recalling Levothyroxine and Liothyronine after FDA issues import alert affecting the active ingredient.
August 10, 2018
The agency issued a warning letter to Canadian API manufacturer, Les Produits Chimiques B.G.R, citing cGMP violations at its API facility in Pointe-Claire, Quebec.
August 07, 2018
The agency issued a draft guidance on developing new medication-assisted treatments for opioid-use disorder.
August 02, 2018
More consistent and reliable production processes are critical for advancing innovative treatments.