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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.
November 29, 2021
PathoQuest is the first French contract research organization (CRO) capable of offering GMP grade NGS-based testing services for quality control of biological drugs.
November 26, 2021
Biogen received MHRA marketing authorization for VUMERITY (diroximel fumarate) for treatment of relapsing-remitting multiple sclerosis (RRMS).
November 25, 2021
The EC has granted marketing authorization for Gilead’s Trodelvy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer.
November 19, 2021
FDA has amended its EUA for Pfizer-BioNTech’s and Moderna’s COVID-19 booster to include all individuals aged 18 or older.
Jordi Serrat, Product & Technology Director, Azbil Telstar talks about the role of disruptive and digital technologies in aseptic processing.
Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.
GSK has been granted approval by the EC for its monoclonal antibody therapy, Nucala (mepolizumab), as a treatment for three additional eosinophil-driven diseases.
AbbVie's SKYRIZI (risankizumab) has gained approval for the treatment of active psoriatic arthritis in adults, which is the therapy’s second indication in the European Union.
EC has granted marketing authorization for Celltrion's Regkirona (regdanvimab, CT-P59) as a treatment for adults with COVID-19.
Novavax has announced that EMA has started its review of a conditional marketing authorization application for its COVID-19 vaccine, NVX-CoV2373.