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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 24, 2022
EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union.
May 23, 2022
PTC Therapeutics has received a positive opinion from EMA for Upstaza for the treatment of AADC deficiency.
The final guidance addresses safety aspects of container and carton labeling design.
May 20, 2022
The agency is asking drug manufacturers to ensure a strong supply chain by developing risk management plans.
FDA has approved Mounjaro (tirzepatide) injections as a treatment to improve blood sugar control in adults with type 2 diabetes.
May 18, 2022
Pfizer and BioNTech’s COVID-19 vaccine has been granted EUA for booster doses in children five through 11 years of age.
The companies have reached an agreement with the European Commission to update their COVID-19 vaccine supply agreement.
May 17, 2022
In this episode of the Drug Solutions Podcast, Chris Spivey, editorial director, interviews Michael Kopcha, Sau Lee, and Cindy Buhse of FDA about not being afraid to try new approaches and how they invite fresh ideas and abundant communication.
May 15, 2022
Several steps need be taken to achieve lights-out, fully automated operations.
May 11, 2022
The agency’s Center for Drug Evaluation and Research has launched the new program to increase development of treatment options for patients with rare diseases.