Quality Systems

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.

Changes Afoot in Pharmaceutical Laws and Regulations in Spain

April 02, 2023

Proposed regulatory changes signal a major overhaul of legislation governing pharmaceuticals and healthcare in Spain.

The Relationship Between CAPAs and Data: What’s the Right Balance?

April 02, 2023

A risk assessment should be performed as part of the CAPA process, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

Legislative Hold-Up

April 02, 2023

A further setback to the publication of the pharmaceutical legislative changes in Europe may mean time is running out for appropriate review before 2024 parliamentary elections.

FDA Approves Evkeeza for Young Children with Ultra-Rare Form of High Cholesterol

March 31, 2023

FDA has approved Evkeeza for young children with homozygous familial hypercholesterolemia.

Takeda Gets Approval in Japan for Entyvio Subcutaneous Injection

March 30, 2023

Takeda received approval in Japan for a subcutaneous injection formulation of Entyvio (vedolizumab) for treating ulcerative colitis.