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.

FDA Approves Gamida Cell’s Cell Therapy for Treating Blood Cancers

April 18, 2023

Gamida Cell’s therapy is meant to reduce the risk of infection following stem cell transplantation.

Caribou Biosciences Gets FDA Granted Fast Track Designation for Allogeneic CAR-T Cell Therapy

April 14, 2023

FDA has granted fast track designation to Caribou Biosciences for its allogeneic CAR-T cell therapy for relapsed or refractory multiple myeloma.

Pharma Leaders Rebuke Federal Judge’s Ruling on FDA Authority

April 11, 2023

A document signed by members of more than 400 companies and investment firms decries the decision made by a federal judge concerning mifepristone, a medication used in abortions.

FDA Regulatory Authority Under Attack

April 10, 2023

Will court challenges to FDA’s oversight authority open the door for multiple lawsuits to block agency decisions on all sides?

FDA Is Hiring!

April 07, 2023

The agency is dealing with high demand for staff because of a surge in the development of cell and gene therapies.

FDA Backs Randomized Trials for Accelerated Drug Approval

April 07, 2023

FDA aims to address mounting criticisms of its accelerated approval pathway.

Empowering Pharmaceutical Quality Control Laboratories through Strategic Change Management

April 05, 2023

Change management is central to the evolution of quality control laboratories, but what factors can maximize patient outcomes?

Quality Challenges Associated with Cryo/Lyoprotectants

April 03, 2023

Impurities and batch-to-batch variability present the biggest challenges.

A New Hope for Children Living with HIV

April 02, 2023

New child-friendly treatment options and initiatives are improving the outlook of children living with HIV in Europe.

Kudos and Hurdles in Tackling Rare Diseases

April 02, 2023

FDA has spurred investment to create and develop 600 therapies.