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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.
March 29, 2021
Celltrion Group has revealed that EMA's CHMP has issued a positive scientific opinion for regdanvimab (CT-P59)—an anti-COVID-19 monoclonal antibody treatment candidate.
The Janssen Pharmaceutical Companies of Johnson & Johnson revealed that EMA's CHMP has issued a positive opinion for Ponvory (ponesimod) for the treatment of RMS.
The need for added revenues to fund billion-dollar infrastructure improvements has fueled challenges to industry pricing practices.
The company is recalling the product because of crystallization in vials.
The agency’s human medicines committee has approved new manufacturing sites for COVID-19 vaccines.
March 24, 2021
Is FDA approving too many new drugs and added indications too quickly based on surrogate endpoints that fail to pan out?
The agency says that data do not support the use of ivermectin to prevent or treat COVID-19 outside of clinical trials.
March 22, 2021
To maintain business continuity and employee safety during the pandemic, many companies have begun tracking and maintaining records of employee health information.
March 19, 2021
MHRA and EMA have confirmed that the benefits of the AstraZeneca COVID-19 vaccine continue to outweigh the risk of side effects.
BIA has released comments urging the UK government to take a science-based approach to the regulatory framework for gene editing and GMOs.