It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Steps Towards Demystifying Risk-Based Decision Making

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Computer Validation Confirms Evidence

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.

Digitalization of QbD Risk Assessments

Topic

Articles

The updated vaccine will be ready to ship following a positive European Commission review. 

Pfizer and BioNTech Get Positive Opinion in Europe for Omicron XBB.1.5-adapted COVID-19 Vaccine

This is the first biosimilar to Tysabri, an injection for adults with multiple sclerosis. 

FDA Approves Biosimilar to Treat Multiple Sclerosis

Videos

Adam Smith, a House of Representatives member representing Washington's 9th congressional district, discusses the state of U.S. healthcare and pharma.

Discussing the State of Pharma with Congressman Adam Smith

The patent grants Alterity 20 years of exclusivity over a new class of iron chaperone drug candidates. 

Alterity Therapeutics Given European Composition of Matter Patent for Neurodegenerative Diseases

Feliza Mirasol is the science editor for 

FDA has approved a new mAb therapy from Regeneron Pharmaceuticals as well as a higher dose version of Eylea, the company’s eye disease therapeutic.

Regeneron Gets FDA Approvals on New Biologic and New High Dose for Eye Disease Therapy

The immunization, meant to protect infants aged six months or lower, is given to pregnant individuals at a gestation period of 32 to 36 weeks.

Vaccine for Respiratory Syncytial Virus in Infants Granted Breakthrough Therapy Designation

Ipsen’s Sohonos (palovarotene) capsules are designed to reduce new, abnormal bone formation in soft and connective tissues in individuals with fibrodysplasia ossificans progressiva, a rare bone disease.


FDA Approves Ipsen Fibrodysplasia Ossificans Progressiva Treatment

FDA has halted enrollment in clinical studies for Gilead Sciences’ magrolimab, a biologic treatment in development for acute myeloid leukemia.

FDA Halts Clinical Trial Enrollment for Gilead’s Magrolimab in AML Studies

The assessment aims to determine whether valproate use in men could lead to neurodevelopmental disorders in their children.  

EMA Reviews Data on Paternal Exposure to Valproate

The indication for Pombiliti is a long-term enzyme replacement therapy (ERT) used in combination with miglustat for adults with late-onset Pompe disease (LOPD).

Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

Computer Validation Confirms Evidence

Digitalization of QbD Risk Assessments