OR WAIT null SECS
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.
October 14, 2021
MHRA has awarded an ‘Innovation Passport’ to CellResearch for its umbilical cord lining stem cell therapy, CorLiCyte.
October 08, 2021
The approval of ChemoCentryx’s Tavenos (avacopan) provides a new treatment for active anti-neutrophil cytoplasmic autoantibody-associated vasculitis.
AstraZeneca’s tezelpelumab was granted orphan drug designation by FDA for the treatment of eosinophilic esophagitis.
October 07, 2021
FDA’s emergency use authorization will double rapid at-home COVID-19 testing capacity.
The agency has concluded that an extra dose of the COVID-19 vaccines may be given to those individuals with severely weakened immune systems.
The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.
October 04, 2021
Vaccine access campaigners have projected a request to waive vaccine patents onto the hotel where the annual conservative party conference is being held.
October 03, 2021
Part 1 of this article series demonstrates, using real-world process data, that the four fundamental assumptions underlying the classical Shewhart control charts—randomness, independence, constant average, and constant variation—are often not met.
October 02, 2021
Almost half of pharmaceutical industry profits continue to come from biopharmaceuticals.
Updates to Ph. Eur. include validated tests for N-nitrosamine impurities in sartan APIs.