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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.
January 02, 2022
DTx manufacturers are taking advantage of the new regulatory flexibility, afforded by the COVID-19 pandemic, to pilot new products and generate real-world evidence to support regulatory filing and reimbursement.
Continued process verification for a cleaning validation program begins once the validation study is complete.
As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority.
Siegfried Schmitt, vice president Technical at Parexel, discusses the difficulty of operating non-GMP and GMP quality systems in the same facility.
To maintain smooth operations, FDA is relying on swift reauthorization of industry-paid user fee programs.
Overall, 2021 proved to be another good year for drug approvals in Europe, albeit with a slight disappointment for Alzheimer’s patients, but what should industry be watching out for in 2022?
January is the kind of month that can make your head spin.
December 22, 2021
Tezpire (tezepelumab-ckko) has been approved as an add-on maintenance treatment for severe asthma.
December 20, 2021
The agency recommended granting conditional marketing authorization for use of Nuvaxovid in people 18 years of age and older.
December 17, 2021
FDA has become embroiled in the debate over access to “chemical” or “medication” abortions through the prescribing and distribution of the abortifacient mifepristone.