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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 25, 2021
The final guidance document provides recommendations for regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs.
The guidance addresses implementation of amendments made by the FDA Reauthorization Act of 2017.
May 24, 2021
The agency’s human medicines committee concluded sotrovimab can be used to treat COVID-19 in adults and adolescents who do not require supplemental oxygen therapy and are at risk for severe COVID-19.
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.