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.
January 02, 2022
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.
December 16, 2021
General agreement that FDA needs a confirmed commissioner may speed Califf’s appointment.
The European Medicines Agency has accepted Sanofi’s marketing authorization application for olipudase alfa, a potential new therapy for acid sphingomyelinase deficiency, a rare disease.
FDA approved American Regent’s Injectafer (ferric carboxymaltose injection) for the treatment of pediatric patients with iron deficiency anemia.
December 15, 2021
GlaxoSmithKline and Vir Biotechnology have received a conditional marketing authorization from MHRA for Xevudy (sotrovimab) in the treatment of COVID-19.
December 10, 2021
Guide addresses challenges of applying GMPs to autologous cell therapy manufacturing.