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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.
November 20, 2017
The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.
November 16, 2017
Commissioner Scott Gottlieb, MD, outlined a plan to support innovation of regenerative medicines while ensuring public safety.
November 15, 2017
The company is voluntarily recalling one lot of NEXTERONE 150 mg/100 mL Premixed Injection because of particulate matter found in the solution.
November 14, 2017
Commissioner Scott Gottlieb issued a statement warning about the risks associated with kratom.
The agency approved Abilify MyCite, a pill with a sensor that digitally tracks if patients have ingested their medication.
November 13, 2017
Investing in a single source enterprise-wide LMS to fuel risk management and mitigation offers multi-dimensional return on investment.
November 10, 2017
Two of the medicines recommended for approval are orphan drugs.
The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.
The company expects to commercially launch the new vaccine in the US in the first quarter of 2018.
November 09, 2017
FDA is exploring ways to keep branded drug companies from using REMS to block the development of generic drugs.