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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 21, 2021
Developing and manufacturing a therapy in a regulated environment demands careful adherence to quality practices.
The agency is authorizing extending the time undiluted, thawed vaccine vials can be stored in the refrigerator to one month.
May 20, 2021
The guidance provides a framework for the management of postapproval chemistry, manufacturing, and controls changes.
The guidance document gives recommendations to support biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System-based waiver of the in-vivo bioequivalence study requirement for drugs.
The agency has published multiple guidance documents and policy initiatives for updating and advancing the clinical research process.
May 19, 2021
The agency’s human medicines committee has recommended extending the approved storage period of unopened thawed vials at 2–8 0C from five days to 31 days.
May 18, 2021
Sanofi and GlaxoSmithKline reported that their adjuvanted recombinant COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in a Phase II trial.
May 15, 2021
Industry experts discuss how FDA’s response to COVID-19 and related pandemic-related guidance documents may impact the biologics industry long term.
May 12, 2021
FDA expects to conduct only a small portion of scheduled facility visits in 2021 due to continued limitations on travel imposed by the COVID-19 pandemic.
May 11, 2021
Adolescents are now eligible for the Pfizer-BioNTech COVID-29 vaccine under expanded EUA.