Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

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

Computer Validation Confirms Evidence

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

Digitalization of QbD Risk Assessments

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.

Congress Slated to Reauthorize User Fees Without FDA “Improvements”

September 23, 2022

Legislative leaders are looking to approve a bare-bones measure to fund FDA operations as part of a short-term government funding bill.

The Manufacturing Edge on Path to Market

September 22, 2022

FDA backs the benefits of adopting continuous manufacturing, a strategy which has accelerated approval and launch timelines, and its Emerging Technology Program could be a helpful tool.

FDA Approves Bluebird Bio’s $3 Million CALD Treatment

September 21, 2022

FDA granted accelerated approval to Skysona (elivaldogene autotemcel), which is designed to slow the progression of neurologic dysfunction in adolescents with CALD.

Clinical Trial Modernization Raises FDA Compliance Issues

September 20, 2022

Regulatory officials are addressing challenges in ensuring that clinical data can be relied on in making regulatory decisions.

High-Quality Glass Improves Confidence in Analytes Measurement

September 20, 2022

Choosing low-adsorption glass vials helps ensure detection accuracy.

EC Approves Lupkynis for Treatment of Active Lupus Nephritis

September 20, 2022

Otsuka announced that the EC has approved Lupkynis as the first oral treatment for active lupus nephritis.

EMA Recommends Approval of Enjaymo

September 16, 2022

EMA has recommended approval of Enjaymo for the treatment of hemolytic anemia in adult patients with cold agglutinin disease.

Advanced Biopharma Manufacturing Key to White House Cancer Moonshot

September 16, 2022

The White House hopes to expand US modern biotech manufacturing and reduce reliance on foreign sources of bioindustrial materials.

WHO Grants Prequalification to GSK’s Malaria Vaccine

September 14, 2022

WHO has awarded prequalification to GSK’s Mosquirix, an approved malaria vaccine.

FDA In Limbo as User Fee Renewal Stuck on Capitol Hill

September 09, 2022

FDA is in jeopardy of losing its fees for assessing and approving new drugs and medical products.