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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.
December 23, 2020
The agency is targeting websites that market untested CBD products as medical treatments.
Customceutical Compounding was sent a warning letter by FDA after investigators found deficiencies in the production of sterile drug products.
The agency is organizing a second public meeting on January 8, 2021 to discuss the assessment, approval, and roll-out of new COVID-19 vaccines.
December 21, 2020
The guidance provides information on review timelines during the COVID-19 pandemic.
A decision by the European Commission on conditional marketing authorization for the European Union’s first COVID-19 vaccine is expected soon.
December 18, 2020
The new guidance provides information on how sponsors should interact with the agency regarding complex innovative trial design proposals.
The agency is answering frequently asked questions about the Pfizer–BioNTech COVID-19 vaccine on its website.
FDA is expected to issue Emergency Use Authorization for Moderna’s vaccine, enabling immediate distribution.
December 16, 2020
The product represents a first-of-its-kind intentional genomic alteration in a line of domestic pigs that may be used for human therapeutics.
December 15, 2020
Trixeo Aerosphere—AstraZeneca’s triple-combination COPD therapy—has been approved for use in the European Union (EU).