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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.
June 22, 2021
EMA's recent positive opinion for a recombinant vaccine for rabbits developed using Algenex’s proprietary and patent protected Baculovirus vector-mediated expression platform, CrisBio, should push the full commercialization of the platform forward.
Thought and foresight into method development stages can ensure costly errors and delays are avoided later on.
June 21, 2021
The root cause of the most serious integrity issues has generally been a lapse of ethical behavior on the part of an individual.
The final guidance document is intended to help determine which reporting category is appropriate for a change in CMC information to an approved biologics application.
The guidance provides recommendations for including premenopausal women in breast cancer clinical trials.
June 18, 2021
The US government will invest $3 billion from the American Rescue Plan into a COVID-19 antiviral development strategy.
June 14, 2021
Automated systems help detect and resolve quality issues.
The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.
June 11, 2021
As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility.
The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.